[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"covid-19\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:covid-19":609},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,125,0,25,[9,51,64,98,126,148,176,197,223,250,276,301,333,351,378,402,423,445,466,487,503,526,560,581,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054120","phase-1-a-safety-and-immunogenicity-trial-of-ocu500-chad36-vector-encoding-sars-cov-2-spike-vaccine-via-intranasal-and-inhalational-routes-in-previously-vaccinated-adults-100054120",false,"NCT07536308","A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults","A Phase 1 Open-Label Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike, A Next-Generation SARS-CoV-2 Booster Vaccine Via Intranasal and Inhalational Routes, in Previously Vaccinated Adults","Inclusion Criteria:\n\n1. Provides written informed consent before initiation of any study procedures.\n2. Able to understand and agree to comply with planned study procedures and be available for all study visits.\n3. Non-pregnant adults, 18 through 64 years of age at the time of study product administration.\n4. Participants of childbearing potential\\* must agree to use or have practiced true abstinence\\*\\* or use at least one acceptable primary form of contraception.\\*\\*\\*\n\n   \\*These criteria apply to females who are in a heterosexual relationship and are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation\u002Fsalpingectomy).\n\n   \\*\\*True abstinence is 100 percent of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods.\n\n   \\*\\*\\*Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, a copper intrauterine device, a levonorgestrel-releasing intrauterine device, a progestin-only oral contraceptive pill, a depot medroxyprogesterone injection, or a progestin implant. Combined hormonal contraceptives containing estrogen, including combined oral contraceptive pills, transdermal patches, and vaginal rings, are not acceptable for this trial. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.\n5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.\n6. In general, good health.\\*\n\n   \\*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses\u002Fconditions that have been present for at least 90 days, which would affect the assessment of participant safety. Chronic medical diagnoses\u002F conditions should be stable for the last 30 days (i.e., no hospitalization, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis or condition within the 30 days preceding the study product administration. Any prescription change that is due to a change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.\n7. Receipt of a complete primary COVID-19 vaccine series and at least one booster\\* with last vaccination at least 16 weeks before study product administration.\n\n   \\*Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized\u002Flicensed vaccine, though doses may have been received as part of a clinical trial.\n8. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.\\*\n\n   \\*(White Blood Cells \\[WBCs\\] with differential \\[diff\\], hemoglobin \\[Hgb\\], platelets \\[PLTs\\], PTT, PT, Alanine Transaminase \\[ALT\\], Aspartate Transaminase \\[AST\\], Creatinine \\[Cr\\], Alkaline Phosphatase \\[ALP\\], Total Bilirubin \\[T. Bili\\]). ALT, AST, ALP, T. Bili, and creatinine values that are below the reference range will not be exclusionary, as these values below the reference range are clinically insignificant.\n9. Must agree to have samples stored for secondary research.\n10. Must complete a Test of Understanding (ToU) before enrollment by answering 90 percent of questions correctly at least once in 3 attempts.\n\nExclusion Criteria:\n\n1. Positive SARS-CoV-2 PCR at screening.\n2. Abnormal vital signs (Grade 1 or higher).\\*\n\n   \\*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) = 141 mmHg or = 89 mmHg Diastolic blood pressure (DBP) = 91 mmHg Heart rate (HR) is = 101 beats per minute or = 54 beats per minute Oral temperature = 38.0 degrees Celsius (100.4 degrees Fahrenheit)\n3. History of SARS-CoV-2 infection within the prior 16 weeks OR receipt of any COVID-19 vaccine within the prior 16 weeks before study product administration.\n4. Participant who is pregnant or breastfeeding or less than 12 weeks post partum at the time of study product administration.\n5. Participant has donated blood or plasma within 4 weeks prior to study product administration, or does not agree to refrain from blood or plasma donation until Day 181.\n6. Receipt of antibody or blood-derived products within 90 days before study product administration.\n7. Any significant medical or psychiatric diseases or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.\\*\n\n   \\*Significant self-reported or medically reported medical or psychiatric conditions include, but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, history of hematologic malignancies, ongoing malignancy or recent diagnosis of malignancy in the last five years, excluding treated basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ, which are allowed.\n8. Any respiratory disease, including but not limited to chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis, etc.\n9. Neurological or neurodevelopmental conditions.\\*\n\n   \\*These conditions include: history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, myelopathy, peripheral neuropathy, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.\n10. Cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia.\n11. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.\n12. Any significant nasal or upper airway disease.\\*\n\n    \\*Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head\u002Fneck radiation history, anosmia\u002Fdysosmia, conditions that require prescription or over the counter intranasal medication (intermittent use will be allowed if no use occurred for 30 days before study product administration and participant agrees to not use intranasal medication (other than steroids) for 30 days after study product administration and to not use intranasal steroids for 6 months after study product administration), and certain ear, nose and throat (ENT) conditions, including significant upper airway\u002Fnasopharyngeal disease or abnormal anatomy such as CSF leak.\n13. Has an acute illness, as determined by the site Principal Investigator or appropriate sub-investigator within 72 hours before study product administration.\\*\n\n    \\*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.\n14. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen\u002Fantibody test at screening.\n15. Has any confirmed or suspected immunosuppressive or immunodeficient state, such as asplenia, recurrent severe infections, and chronic\\* immunosuppressant medication within the past 6 months.\\*\\*\n\n    \\*Chronic meaning more than 14 continuous days.\n\n    \\*\\*Ophthalmic and topical steroids are allowed, see exclusions 12 and 21 for intranasal steroids.\n16. Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before study product administration; or is planning to receive one during the study.\n17. Has a history of hypersensitivity or severe allergic reaction\\* to any previous licensed or unlicensed vaccine or to the candidate vaccine components.\n\n    \\*e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction\n18. History of chronic idiopathic urticaria.\n19. Received or plans to receive licensed inactivated\u002Fsubunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.\n20. Plan to receive a COVID-19 vaccine within the 180 days following study product administration.\n21. Regular use of intranasal medications, including steroids.\\*\n\n    \\*Participant must have had no intranasal medication use for 30 days before study product administration and plans not to use intranasal medications for 30 days after study product administration for medications other than steroids, and for 6 months after study product administration for intranasal steroids (including over-the-counter fluticasone).\n22. History of smoking within three months before enrollment.\\*\n\n    \\*Including cigarettes, smokeless and other tobacco products, e-cigarettes (to include vaping and Juuling products), marijuana, nicotine gum, and nicotine lozenges.\n23. Use of intranasal illicit drugs in the 5 years before study product administration or plans to use during the study.\n24. Planned international travel between study product administration and Day 29.\n25. Previous receipt of any adenovirus-vector vaccine by the intranasal or aerosol routes.\n26. Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following Intramuscular injections or venipuncture.\n27. Recent (within 3 months of study product administration): major surgery, \\>=3 days immobility, chronic infection, or head trauma that may increase thrombosis risk.\\*\n\n    \\*Major surgery is either abdominal or vascular, or orthopedic surgery, and immobility implies bed rest.\n28. History of venous or arterial thrombosis or any known thrombophilic condition, including heparin-induced thrombocytopenia (HIT) or thrombosis.\n29. BMI \\>\u002F= 40kg\u002Fm\\^2\n30. Current\u002Fplanned systemic estrogen therapy, except stable transdermal estradiol, from 30 days pre-dose through end of study participation. Low-dose vaginal estrogen is permitted.",true,"ALL","18 Years","64 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This phase 1 randomized, open-label, dose-escalation clinical trial evaluates the safety and immunogenicity of OCU500, a ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine, in healthy adults aged 18-64 who previously completed a primary COVID-19 vaccination series and at least one booster. The study evaluates two dose levels (1×10\\^10 viral particles (VP) and 5×10\\^10 VP) and two routes of administration (intranasal and inhaled). The trial includes 80 participants across four study arms (20 per arm). The primary objective is to evaluate the safety and reactogenicity of a single dose of OCU500 administered in previously vaccinated healthy adults.",[29],"COVID-19",[31,32,33,34,35,36,37],"coronavirus","COVID","Next Generation","OCU500","Open-label","Phase I","vaccine","RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2026-05-26",{"date":46,"type":23},"2027-11-01",{"name":48,"class":49},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",6,{"id":52,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":27,"conditions":56,"keywords":57,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":63,"locationsCount":50},"100634178","Inclusion Criteria:\n\n1. Provides written informed consent before initiation of any study procedures.\n2. Able to understand and agree to comply with planned study procedures and be available for all study visits.\n3. Non-pregnant adults, 18 through 64 years of age at the time of study product administration.\n4. Participants of childbearing potential\\* must agree to use or have practiced true abstinence\\*\\* or use at least one acceptable primary form of contraception.\\*\\*\\*\n\n   \\*These criteria apply to females who are in a heterosexual relationship and are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation\u002Fsalpingectomy).\n\n   \\*\\*True abstinence is 100 percent of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods.\n\n   \\*\\*\\*Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, a copper intrauterine device, a levonorgestrel-releasing intrauterine device, a progestin-only oral contraceptive pill, a depot medroxyprogesterone injection, or a progestin implant. Combined hormonal contraceptives containing estrogen, including combined oral contraceptive pills, transdermal patches, and vaginal rings, are not acceptable for this trial. Must have used at least one acceptable primary form of contraception for at least 30 days before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.\n5. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.\n6. In general, good health.\\*\n\n   \\*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses\u002Fconditions that have been present for at least 90 days, which would affect the assessment of participant safety. Chronic medical diagnoses\u002F conditions should be stable for the last 30 days (i.e., no hospitalization, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis or condition within the 30 days preceding the study product administration. Any prescription change that is due to a change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.\n7. Receipt of a complete primary COVID-19 vaccine series and at least one booster\\* with last vaccination at least 16 weeks before study product administration.\n\n   \\*Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized\u002Flicensed vaccine, though doses may have been received as part of a clinical trial.\n8. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion.\\*\n\n   \\*(White Blood Cells \\[WBCs\\] with differential \\[diff\\], hemoglobin \\[Hgb\\], platelets \\[PLTs\\], PTT, PT, Alanine Transaminase \\[ALT\\], Aspartate Transaminase \\[AST\\], Creatinine \\[Cr\\], Alkaline Phosphatase \\[ALP\\], Total Bilirubin \\[T. Bili\\]). ALT, AST, ALP, T. Bili, and creatinine values that are below the reference range will not be exclusionary, as these values below the reference range are clinically insignificant.\n9. Must agree to have samples stored for secondary research.\n10. Must complete a Test of Understanding (ToU) before enrollment by answering 90 percent of questions correctly at least once in 3 attempts.\n\nExclusion Criteria:\n\n1. Positive SARS-CoV-2 PCR at screening.\n2. Abnormal vital signs (Grade 1 or higher).\\*\n\n   \\*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) = 141 mmHg or = 89 mmHg Diastolic blood pressure (DBP) = 91 mmHg Heart rate (HR) is = 101 beats per minute or = 54 beats per minute Oral temperature = 38.0 degrees Celsius (100.4 degrees Fahrenheit)\n3. History of SARS-CoV-2 infection within the prior 16 weeks OR receipt of any COVID-19 vaccine within the prior 16 weeks before study product administration.\n4. Participant who is pregnant or breastfeeding or less than 12 weeks post partum at the time of study product administration.\n5. Participant has donated blood or plasma within 4 weeks prior to study product administration, or does not agree to refrain from blood or plasma donation until Day 181.\n6. Receipt of antibody or blood-derived products within 90 days before study product administration.\n7. Any significant medical or psychiatric diseases or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.\\*\n\n   \\*Significant self-reported or medically reported medical or psychiatric conditions include, but are not limited to drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, history of hematologic malignancies, ongoing malignancy or recent diagnosis of malignancy in the last five years, excluding treated basal cell and squamous cell carcinoma of the skin, and cervical carcinoma in situ, which are allowed.\n8. Any respiratory disease, including but not limited to chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis, etc.\n9. Neurological or neurodevelopmental conditions.\\*\n\n   \\*These conditions include: history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, myelopathy, peripheral neuropathy, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease.\n10. Cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia.\n11. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.\n12. Any significant nasal or upper airway disease.\\*\n\n    \\*Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head\u002Fneck radiation history, anosmia\u002Fdysosmia, conditions that require prescription or over the counter intranasal medication (intermittent use will be allowed if no use occurred for 30 days before study product administration and participant agrees to not use intranasal medication (other than steroids) for 30 days after study product administration and to not use intranasal steroids for 6 months after study product administration), and certain ear, nose and throat (ENT) conditions, including significant upper airway\u002Fnasopharyngeal disease or abnormal anatomy such as CSF leak.\n13. Has an acute illness, as determined by the site Principal Investigator or appropriate sub-investigator within 72 hours before study product administration.\\*\n\n    \\*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.\n14. Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen\u002Fantibody test at screening.\n15. Has any confirmed or suspected immunosuppressive or immunodeficient state, such as asplenia, recurrent severe infections, and chronic\\* immunosuppressant medication within the past 6 months.\\*\\*\n\n    \\*Chronic meaning more than 14 continuous days.\n\n    \\*\\*Ophthalmic and topical steroids are allowed, see exclusions 12 and 21 for intranasal steroids.\n16. Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before study product administration; or is planning to receive one during the study.\n17. Has a history of hypersensitivity or severe allergic reaction\\* to any previous licensed or unlicensed vaccine or to the candidate vaccine components.\n\n    \\*e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction\n18. History of chronic idiopathic urticaria.\n19. Received or plans to receive licensed inactivated\u002Fsubunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.\n20. Plan to receive a COVID-19 vaccine within the 180 days following study product administration.\n21. Regular use of intranasal medications, including steroids.\\*\n\n    \\*Participant must have had no intranasal medication use for 30 days before study product administration and plans not to use intranasal medications for 30 days after study product administration for medications other than steroids, and for 6 months after study product administration for intranasal steroids (including over-the-counter fluticasone).\n22. History of smoking within three months before enrollment.\\*\n\n    \\*Including cigarettes, smokeless and other tobacco products, e-cigarettes (to include vaping and Juuling products), marijuana, nicotine gum, and nicotine lozenges.\n23. Use of intranasal illicit drugs in the 5 years before study product administration or plans to use during the study.\n24. Planned international travel between study product administration and Day 29.\n25. Previous receipt of any adenovirus-vector vaccine by the intranasal or aerosol routes.\n26. Bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following Intramuscular injections or venipuncture.\n27. Recent (within 3 months of study product administration): major surgery, \\>=3 days immobility, chronic infection, or head trauma that may increase thrombosis risk.\\*\n\n    \\*Major surgery is either abdominal or vascular, or orthopedic surgery, and immobility implies bed rest.\n28. History of venous or arterial thrombosis or any known thrombophilic condition, including heparin-induced thrombocytopenia (HIT) or thrombosis.\n29. BMI \\>\u002F= 40kg\u002Fm\\^2",{"count":22,"type":23},[26],[29],[31,32,33,34,35,36,37],"2026-06-25",{"date":60,"type":42},"2026-06-26",{"date":44,"type":42},{"date":46,"type":23},{"name":48,"class":49},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":24,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100347835","phase-3-phase-iii-das181-lower-tract-piv-infection-in-immunocompromised-subjects-substudy-das181-for-covid-19-rct-study-100347835","NCT03808922","Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study","A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects","Inclusion Criteria:\n\n1. At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.\n2. Immunocompromised, as defined by one or more of the following:\n\n   * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past\n   * Received a solid organ transplant at any time in the past\n   * Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and\u002For solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past\n   * Has an immunodeficiency due to congenital abnormality (only applicable to subjects age \\\u003C 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)\n3. Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus\n4. If female, subject must meet one of the following conditions:\n\n   * Not be of childbearing potential or\n   * Be of childbearing potential and have a negative urine\u002Fserum pregnancy test and agrees to practice an acceptable method of contraception\n5. Non-vasectomized males are required to practice effective birth control methods\n6. Capable of understanding and complying with procedures as outlined in the protocol\n7. Provides signed informed consent prior to the initiation of any screening or study-specific procedures\n\nFor COVID-19 sub study:\n\n1. Be ≥18 years of age\n2. Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).\n3. Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)\n4. Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.\n5. Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples\n6. Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study\n\nExclusion Criteria:\n\n1. Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment\n2. Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT\u002FAST\u002FALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \\>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded\n3. Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug\n4. Subjects taking any other investigational drug used to treat pulmonary infection.\n5. Psychiatric or cognitive illness or recreational drug\u002Falcohol use that, in the opinion of the principal investigator, would affect subject safety and\u002For compliance\n6. Subjects with known hypersensitivity to DAS181 and\u002For any of its components\n7. Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria:\n\n   * Has evidence of vital organ failure outside of the lung (e.g., liver, kidney)\n   * Requires vasopressors to maintain blood pressure\n\nFor COVID-19 sub study:\n\n1. Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.\n2. Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).\n3. Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)\n4. Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)\n5. Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria:\n\n   * Have evidence of vital organ failure outside of the lung (e.g., liver, kidney)\n   * Require vasopressors to maintain blood pressure\n6. Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study",{"count":72,"type":23},274,[74],"PHASE3","This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.\n\nIt also contains a sub-study to enroll patients with severe COVID-19.",[77,78,79,29],"Lower Respiratory Tract Infection","Parainfluenza","Immunocompromised",[78,81,79,77,82,83,84,85,86],"PIV","LRTI","COVID19","SARS-CoV-2","Coronavirus","Ansun","2026-06-18",{"date":89,"type":42},"2026-06-23",{"date":91,"type":42},"2019-05-23",{"date":93,"type":23},"2028-09-01",{"name":95,"class":96},"Ansun Biopharma, Inc.","INDUSTRY",28,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":107,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100644077","phase-1-evaluation-of-the-safety-and-efficacy-of-xoglo-pro-a-placental-mesenchymal-stem-cell-derived-extracellular-vesicles-in-treating-covid-19-symptoms-100644077","NCT07664696","Evaluation of the Safety and Efficacy of XoGlo Pro, a Placental Mesenchymal Stem Cell-derived Extracellular Vesicles in Treating COVID-19 Symptoms","A Stratified Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase I\u002FIIa Clinical Trial to Assess the Safety and Efficacy of a Single Intravenous Dose of Isolated, Placental, Mesenchymal Stem Cell-derived Extracellular Vesicles for the Treatment of COVID-19 Symptoms in Adults With Mild to Moderate Illness","Inclusion Criteria:\n\n1. Adult subjects of either gender aged more than 18 years.\n2. Body Mass index (BMI) between ≥25 and ≤39.9 kg\u002Fm2.\n3. Duration (in days) of COVID-19 symptoms prior to randomization is a \\> 2 days and ≤ 10 days of COVID-19 symptoms.\n4. Two (2) positive (rapid) antigen diagnostic tests for SARS-CoV-2 (tests listed under FDA EUA) and administered within 2 hours of each other. Enrolled subjects will undergo subsequent molecular standard reverse transcriptase polymerase chain reaction (rt-PCR) assay. Enrolled subjects with a negative PCR test will be replaced by other individuals.)\n5. Subjects with a minimal baseline severity score for COVID-19-related symptoms defined as at least two symptoms with a score of 2 or higer, using normalized grading scale.\n6. Female subjects of non-childbearing potential (e.g., non fertile, pre-menarche, permanently sterile \\[e.g., underwent hysterectomy, bilateral salpingectomy or bilateral ovariectomy\\] or post-menopausal \\[history of no menses for at least 12 months without an alternative medical cause\\] or Woman of childbearing potential\\* with a negative serum or urine pregnancy test\n\nExclusion Criteria:\n\n1. Subjects who test positive for SARS-CoV-2 using a virologic test but have no symptoms consistent with COVID-19. (Asymptomatic or presymptomatic infection).\n2. Subjects who have SpO2 \\\u003C94% on room air at sea level (Severe illness).\n3. Subjects who have respiratory failure (Critical illness).\n4. Subjects who have septic shock (Critical illness).\n5. Subjects who have multiple organ dysfunction (Critical illness).\n6. Subjects presenting with an underlying medical condition or risk factor that conclusively disposes that subject to a higher risk for progression to severe COVID-19, as per the CDC's Systematic Review Process.\n7. Subjects hospitalized within the previous 15 days.\n8. Subjects discharged from the Emergency Room within the previous 15 days.\n9. Subjects not expected to survive for three (3) months due to other pre-existing medical conditions such as end-stage neoplasm or other diseases.\n10. Less than 18 years.",{"count":106,"type":23},64,[26,108],"PHASE2","Investigational New Drug trial investigating safety as primary endpoint and clinical efficacy as secondary endpoint of placental, mesenchymal stem cell-derived extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.",[29],[112,113,114,115],"Exosomes","Extracellular Vesicles","EVs","Kimera","NOT_YET_RECRUITING","2026-06-17",{"date":119,"type":42},"2026-06-24",{"date":121,"type":23},"2027-01",{"date":123,"type":23},"2028-12",{"name":125,"class":96},"Kimera Labs Inc.",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":17,"sex":18,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":145,"locationsCount":147},"100393517","serological-and-pcr-testing-for-covid-19-100393517","NCT04404062","Serological and PCR Testing for COVID-19","Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19","Inclusion Criteria:\n\n* Male or female aged 5 to 70 years.\n* An understanding, ability, and willingness to fully comply with the project procedures and restrictions.\n\nExclusion Criteria:\n\n* Not applicable.","5 Years","70 Years",{"count":136,"type":23},2500,"OBSERVATIONAL","Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody tests to help develop methodologies which provide fast and accurate results. Infection with coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19 is crucial to understand who is infected and therefore a risk to others by spreading the infection. RRI are currently carrying out the following tests:\n\nA. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune\n\nB. Polymerase Chain Reaction (PCR) testing using an established method to check for active SARS-CoV-2 infections.\n\nC. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.\n\nThe above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their workforce, as well as their families (including children) and visitors to their site.\n\nCollecting this data allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission.",[29],"2026-06-15",{"date":117,"type":42},{"date":143,"type":42},"2020-03-16",{"date":123,"type":23},{"name":146,"class":96},"Richmond Research Institute",1,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":147},"100642294","phase-3-safety-and-serum-virus-neutralizing-antibody-responses-of-vyd2311-a-covid-19-vaccine-and-coadministered-vyd2311-with-a-covid-19-vaccine-100642294","NCT07655180","Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine","A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Serum Virus Neutralizing Antibody Responses, and Pharmacokinetics of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine","LIBERTY","Inclusion Criteria:\n\n1. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening\n2. Has a body mass index (BMI) 18.0 to 32.0 mg\u002Fkg2, inclusive.\n3. Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, and ECG per study site standard operating procedures.\n\nExclusion Criteria:\n\n1. Prior receipt of VYD2311 or pemivibart (VYD222).\n2. Prior receipt of a COVID-19 vaccine within 6 months before Day 0 and prior receipt of a non-COVID-19 vaccine within 28 days before Day 0.\n3. Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.\n4. Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.\n5. Tests positive for current SARS-CoV-2 infection by RAT or local nucleic acid amplification test (eg, RT-PCR) on Day 0.\n6. Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 0.\n7. Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in the opinion of the investigator or has a fever ≥38oC (≥100.4oF) within 14 days of Day 0.\n8. Any chronic or significant medical condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety or study results.\n\nNOTE: The above information is not intended to contain all considerations relevant to a participant's potential eligibility in the clinical trial.","49 Years",{"count":158,"type":23},210,[74],"The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.",[29],[29,32,163,164,165,154,166,37,167],"mAb","antibody","VYD2311","Invivyd","SARS-CoV-2 Monocloncal antibody","2026-06-12",{"date":117,"type":42},{"date":171,"type":42},"2026-06-08",{"date":173,"type":23},"2026-08",{"name":175,"class":96},"Invivyd, Inc.",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":147},"100457864","prevalence-and-clinical-significance-of-anti-annexin-a2-antibodies-in-covid-19-infection-100457864","NCT05242159","Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection","IMMUNOCOVID","Inclusion Criteria:\n\n* 18 years and older\n* All patients hospitalized in Amiens University Hospital with COVID-19 infection\n\nExclusion Criteria:\n\n* Autoimmune diseases\n* Chronic viral infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV)\n* Immunosuppressive treatment\n* Solid tumors\n* Hematological malignancies",{"count":184,"type":23},300,"In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients.\n\nAnnexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.",[29],[29,188],"annexin A2",{"date":140,"type":42},{"date":191,"type":42},"2021-05-28",{"date":193,"type":23},"2026-06",{"name":195,"class":196},"Centre Hospitalier Universitaire, Amiens","OTHER",{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":24,"phases":206,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":147},"100570114","characterization-of-the-ifn-i-response-in-subjects-who-experienced-severe-or-mild-forms-of-covid-19-100570114","NCT06703034","Characterization of the IFN-I Response in Subjects Who Experienced Severe or Mild Forms of COVID-19","CARE-IF-COVID","Inclusion Criteria:\n\n* Participant aged at least 18 years\n* Previously included in the COVID-ser or NOSO-COR IMMUNO study as well as in the RNIPH study (Research Not Involving Human Persons) named MIR-COVID\n* Weight of 50 kg or more\n\nExclusion Criteria:\n\n* Current infection symptoms\n* Immunosuppression defined by: bone marrow transplant within the past 24 months, chemotherapy within the past 6 months, HIV infection with CD4 \\\u003C200\u002Fmm³ or \\\u003C15%, corticosteroid therapy for more than 2 weeks with a daily dose over 10 mg of prednisolone equivalent, immunosuppressive treatment administered within the previous 3 months (6 months for rituximab), aplasia, asplenia, or splenectomy\n* Pregnant, parturient, or breastfeeding woman\n* Person deprived of liberty by judicial or administrative decision\n* Person receiving psychiatric care\n* Person admitted to a health or social institution for purposes other than research\n* Person under guardianship or curators\n* Person not affiliated with a social security scheme or similar coverage\n* Patient participating in another ongoing interventional research study at inclusion\"",{"count":205,"type":23},134,[207],"NA","Type I interferon (IFN-I) production is triggered by the detection of viral molecules, such as strands of viral RNA or DNA, by receptors known as PRRs (Pattern Recognition Receptors) present on many cell types. These interferons are secreted in minimal concentrations but can activate neighboring cells to secrete over 700 proteins with antiviral properties (inhibition of viral replication, destabilization of viral membranes, etc.). Thus, the IFN-I response serves as the immune system's first line of defense during a viral infection.\n\nVery early in the COVID-19 pandemic, several research teams, including ours, identified a defect in the type I interferon response in about one in five subjects with severe COVID-19. In-depth studies have shown that 5 to 20% of these patients with severe COVID-19 disease have genetic mutations affecting genes involved in the activation cascade of the IFN-I pathway or produce autoantibodies that neutralize IFN-I, significantly impairing the effectiveness of their IFN-I response.\n\nHowever, to date, not all causes of IFN-I response alteration are clearly identified, and 80% of patients suffering from severe COVID-19 do not appear to have evident genetic predispositions or anti-IFN-I autoantibodies, with the techniques currently available. This suggests the presence of other risk factors or causes that could potentially lead to alterations in the IFN-I response.\n\nThe gut microbiota is recognized for its influence on host health and immunity. SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) infection has been associated with altered gut microbiota and correlated with inflammatory and immune responses. However, the association between dysbiosis and IFN-I response has yet to be studied in humans.\n\nTherefore, to improve the management of individuals affected by viral respiratory infections, it seems essential to explore alterations in the IFN-I response to identify individuals potentially at risk of developing severe forms. It is known that a failure in the IFN-I response in the early stages of a viral infection leads to uncontrolled viral replication, which may result in a severe form of the disease. Since this IFN-I response is essential for controlling all viral infections, regardless of the virus involved, the investigators hypothesize that this IFN-I deficiency could be responsible for severe infections from various respiratory viruses that may lead to severe forms, even though a direct association between IFN-I deficiency and higher mortality risk has only been reported for a few viruses, such as SARS-CoV-2 and influenza.\n\nFurthermore, the investigators consider the possibility of other underlying causes of IFN-I deficiencies, distinct from the already observed anti-IFN-I autoantibodies and genetic mutations. To achieve this, the investigators hypothesize that the use of functional immune tests could reveal these other alterations.\n\nBy identifying these alterations in individuals, the investigators hope to more accurately predict their propensity to develop severe forms of viral infections.\n\nPatients who experienced :\n\n* mild forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing COVID-Ser cohort (ClinicalTrial no. NCT04341142)\n* severe forms of COVID-19 during the first wave, without any prior vaccination, selected from the pre-existing NOSO-COR IMMUNO cohort (ClinicalTrial no. NCT04637867) and the RNIPH study (Research Not Involving Human Persons) named MIR-COVID (compliance with MR004 n°20\\_097\\_v2) could be recruited.\n\nBiological samples will be collected specifically for the study, outside of a healthcare procedure. No biological sample in biocollections coming from COVID-ser and NOSO-COR IMMUNO studies and the RNIPH study (Research Not Involving Human Persons) named MIR-COVID will be used for this new protocol.",[29],[29,211,212,213,214],"interferon","disease severity","prognosis","Immune Functional Assays",{"date":216,"type":42},"2026-06-09",{"date":218,"type":42},"2024-12-02",{"date":220,"type":23},"2028-06",{"name":222,"class":196},"Hospices Civils de Lyon",{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":17,"sex":18,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":4,"leadSponsor":249,"locationsCount":147},"100156257","viral-infections-in-healthy-and-immunocompromised-hosts-100156257","NCT01306084","Viral Infections in Healthy and Immunocompromised Hosts","* INCLUSION CRITERIA\n\n  1. The protocol is open to people of all ages;\n\n     1. Only patients greater than or equal to 2 years of age can be enrolled at the Clinical Center.\n     2. Patients who are less than 2 years old may be enrolled only remotely and will not be seen at the Clinical Center.\n  2. a. Persons having (or be suspected of having) a viral infection that is of interest to LID investigators.\n\n     b. Persons that are a close contact of someone who has (or is suspected of having) a viral infection that is of interest to LID investigators or is about to receive or have recently received a viral vaccine.\n\n     c. Persons that may have had a recent viral infection that is of interest to LID investigators that has since cleared\n\n     d. Healthy persons who will serve as controls for (a), (b), or (c) above. These persons will be 18 years of age or older and able to provide informed consent.\n  3. Adults who are unable to provide initial consent may be enrolled providing procedures per Human Research Protections Program (HRPP) Policy 403 have been followed.\n  4. Only subjects that are NIH employees or contractors who work at NIH will be enrolled in the COVID19 antibody cohort study on this protocol.\n\nEXCLUSION CRITERIA\n\n1. Patients who are unable to safely undergo study procedures and tests.\n2. Patients unwilling to have samples collected and stored for future use.\n3. For the healthy controls cohort: persons who are \\\u003C18 years old, decisionally impaired adults, and pregnant women","6 Months","120 Years",{"count":232,"type":23},1000,"Background:\n\n\\- Viral infections are an important cause of illness and death in hospitalized patients as well as outpatients. New strains of viruses may appear and infect both healthy people and those with weak immune systems. A better understanding of these new virus strains (such as SARS-CoV-2, the virus that causes COVID-19) may help to control and prevent these infections. In particular, some viral infections that are less problematic in healthy persons can be life threatening in persons with weak immune systems, and viruses may be able to evolve more rapidly in persons with weak immune systems and therefore develop resistance to existing treatments. Researchers are interested in collecting samples and information from otherwise healthy persons or persons with weak immune systems to study the effects of viruses and their development.\n\nObjectives:\n\n\\- To collect samples and data from individuals who have been exposed to or have contracted viral infections.\n\nEligibility:\n\n* Individuals of all ages who have been diagnosed with a viral infection are suspected to have a viral infection, or have been in close contact with someone with a suspected or actual viral infection that is of interest to investigators in the Laboratory of Infectious Diseases.\n* Healthy persons and persons with weak immune systems (immunocompromised individuals) are eligible to participate.\n\nDesign:\n\n* Participants will be pre-screened to determine if they meet the eligibility criteria for the trial.\n* If eligible, evaluation may include a medical chart review, a history and physical examination, review of clinical reports from outside hospitals and laboratories, and review of tissue biopsies.\n* Study procedures may include collection of blood, urine, saliva, nasal fluid sampling, throat swabs, stool, and genital swabs. For participants who have specimens collected as part of their medical care (e.g. wound swabs, spinal tap, bronchoscopy, liver biopsy etc.), researchers may use leftover specimens from the clinical laboratory for testing.\n* Specimens may be collected up to 4 times per week during the first 2 weeks after enrollment, and then as many as 2 times per week for up to 2 years. Some participants may be asked to continue providing specimens if there is concern for relapse or recurrence of the infection.\n* Treatment is not offered under this study.",[235,29,236],"Anogenital Herpes","Herpes Labialis",[84,238,239,240,85,241,242,243],"Respiratory Infections","Norovirus","Adenovirus","Natural History","Viral Infection","Respiratory Viruses","2026-06-02",{"date":246,"type":42},"2026-06-03",{"date":248,"type":42},"2011-03-15",{"name":48,"class":49},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":275},"100456016","remotely-monitored-mobile-health-supported-multidomain-rehabilitation-program-with-high-intensity-interval-training-for-covid-19-100456016","NCT05218083","REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19","REMM-HIIT-CoV","Inclusion Criteria:\n\n* Primary diagnosis of COVID-19 requiring hospital admission\n* Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)\n* Able to ambulate with or without a gait aid prior to hospital discharge\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Hospital discharge \\> 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge \\> 60 days\n* Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)\n* Functional impairment resulting in inability to exercise at baseline\n* Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction\n* Any absolute contraindications to exercise, including but not limited to:\n\n  * Recent (\\\u003C 5 days) acute primary cardiac event\n  * Unstable Angina\n  * Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise\n  * Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure\n  * Symptomatic aortic stenosis\n  * Uncontrolled symptomatic heart failure\n  * Acute myocarditis or pericarditis\n  * Suspected or known dissecting aneurysm\n* Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure \\\u003C 60 mmHg on 2 consecutive readings within 1 minute)\n* High risk for non-adherence as determined by screening evaluation\n* Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study\n* Pregnant",{"count":258,"type":23},120,[207],"Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.",[29,262,263,264,265],"Critical Illness","ICU Acquired Weakness","PICS","Cardiorespiratory Fitness","2026-05-27",{"date":268,"type":42},"2026-05-28",{"date":270,"type":42},"2023-02-23",{"date":272,"type":23},"2027-04-01",{"name":274,"class":196},"Duke University",5,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":24,"phases":286,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"100523752","evaluation-of-concordance-between-exhaled-air-test-ebam-cov-and-rt-pcr-to-detect-sars-cov-2-100523752","NCT06099795","Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2","Evaluation of Concordance Between an Innovative Test on Exhaled Air (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 in Symptomatic Patients or Closed Contacts","eBAM_CoV","Inclusion Criteria:\n\n* Adult male or female patients over 18 years of age (≥)\n* Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening.\n\nExclusion Criteria:\n\n* Inability to understand the procedures to use the device\n* Patient participating in an another interventional study\n* Patient in exclusion period determined by another study\n* Patient under court protection or guardianship\n* Patient\u002Ftrusted person\u002Flegal representative\u002Ffamily member for whom it is impossible to give informed information.\n* Pregnant, parturient or breast-feeding patient",{"count":285,"type":23},250,[207],"During the COVID-19 pandemic, testing primarily relied on the use of nasopharyngeal swabs to detect the SARS-CoV-2 virus, responsible for the disease. However, this technique has several limitations, including the variable quality of swabs, its invasive nature, and arbitrariness in the choice of the number of cycles. Furthermore, it does not allow for the detection of viral proteins.\n\nTo overcome these limitations, researchers developed the eBAM-CoV test, patented for the detection of viral proteins in the exhaled air of COVID-19 patients. This portable device provides an immediate assessment of the \"viral load\" with both quantitative and qualitative results, showing promise for early virus detection.\n\nThe researchers hypothesize that the eBAM-CoV test is likely to exhibit a satisfactory concordance with the reference RT-PCR test in the detection of COVID-19, especially among symptomatic patients or closed contacts.",[289,29,85],"SARS-CoV-2 Infection",[291],"Diagnostic Test Kits","2026-05-22",{"date":266,"type":42},{"date":295,"type":42},"2025-01-01",{"date":297,"type":23},"2027-12",{"name":299,"class":196},"Centre Hospitalier Universitaire de Nīmes",2,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":17,"sex":18,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":275},"100599839","phase-4-a-study-to-evaluate-the-immunogenicity-and-safety-of-mrna-1283-covid-19-variant-containing-formulations-100599839","NCT07089706","A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations","A Phase 3b\u002F4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations","Inclusion Criteria:\n\nSubprotocol 1:\n\n* ≥65 years of age at the time of signing the informed consent or ≥12 to \\\u003C65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.\n* Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.\n* Participants who are assigned female at birth or could become pregnant:\n\n  i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.\n\nii) Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1).\n\niii) Has agreed to continue adequate contraception through 28 days following vaccine administration.\n\nExclusion Criteria:\n\nSubprotocol 1:\n\n* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.\n* Acutely ill or febrile (temperature ≥38.0°Celsius\u002F≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.\n* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.\n* Receipt of the COVID-19 vaccine within 6 months prior to enrollment.\n* Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.\n* Receipt of systemic immunosuppressants for \\>14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams \\[mg\\]\u002Fday of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.\n* Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.\n* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.\n* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.","12 Years",{"count":310,"type":23},832,[312],"PHASE4","The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.",[29],[316,317,84,318,85,319,320,321,29,322,323],"mRNA-1283","mRNA-1283 vaccine","SARS-CoV-2 Vaccine","Coronavirus Infections","Virus Diseases","mNEXSPIKE®","COVID-19 vaccine","Moderna","2026-05-15",{"date":326,"type":42},"2026-05-19",{"date":328,"type":42},"2025-07-21",{"date":330,"type":23},"2026-06-19",{"name":332,"class":96},"ModernaTX, Inc.",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":339,"targetDuration":340,"studyType":137,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":147},"100640033","smatteo-covid19-registry-smacore-100640033","NCT07597876","SMAtteo COvid19 REgistry (SMACORE)","Inclusion Criteria:\n\n* diagnosis of Covid-19\n\nExclusion Criteria:\n\n\\-",{"count":232,"type":23},"1 Day","Since the start of the COVID-19, Italy, and particularly the Northern region, Lombardia, has initially been the centre of the most numerous reports of confirmed cases of COVID-19 since the spread of the infection to Europe, reaching 5469 cases out of 9172 total cases in Italy (corresponding to 0.054% of the region population) within 2 weeks from the identification of the first Italian case at the end of February 2020. Data updated at 25 March 2020 reported 7503 deaths out of 57521cases in Italy. The overall number of patients requiring admission to hospital reached 23112, with another 3489 needing intensive care unit (ICU) management (4). The \"Fondazione IRCCS Policlinico San Matteo\" Pavia's main teaching and research hospital has become one of the main COVID Centers for the treatment of the disease. Several departments have been reassigned to the sole hospitalization of COVID-19 patients in addition to the Infectious Disease Department and the Intensive Care (ICU). Moreover, a dedicated emergency room (ER) has been set up.\n\nAll these measures have given rise to a large amount of clinical, imaging and laboratory data originating from different sources as well data regarding to type and length of stay in each of the ER, medical departments and ICU, that are of use for diagnostic and prognostic purposes. Also the Fondazione IRCCS Policlinico San Matteo has information obligations towards the Regional (Regione Lombardia) and National (Istituto Superiore di Sanità, ISS) authorities.\n\nFor these reasons we plan to set up a structured registry to collect these information on our Covid-19 patients using the secured REDCap platform resident on a server of the local Informative Services.",[29],"2026-05-14",{"date":326,"type":42},{"date":346,"type":42},"2020-05-20",{"date":348,"type":23},"2028-01",{"name":350,"class":196},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":24,"phases":361,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100564600","phase-3-randomized-double-blind-placebo-controlled-trial-evaluating-baricitinib-on-persistent-neurologic-and-cardiopulmonary-symptoms-of-long-covid-100564600","NCT06631287","Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID","Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID (REVERSE-LC)","REVERSE-LC","INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this investigation, an individual must meet all of the following criteria:\n\nCohort #1 (n=500):\n\n1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.\n2. Age ≥18 years old.\n3. Documented SARS-CoV-2 infection 6 or more months prior to screening, confirmed with acceptable documentation that includes (at minimum) their name, the date the test was taken (must be after January 2020), and details specifying that the positive test was for SARS-CoV-2 infection.\n4. Clinical evidence of Long COVID, as confirmed by the investigator's assessment:\n\n   a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).\n\n   i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory\u002Fconcentration (\"brain fog\"), headache, dysautonomia\u002Fpostural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell\u002Ftaste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.\n\n   b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.\n\n   c. Symptoms must be reported to have an impact on quality of life and\u002For everyday functioning and to be at least somewhat bothersome.\n\n   d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.\n\nCohort #2 (n=50):\n\n1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.\n2. Age ≥18 years old.\n3. Clinical diagnosis of COVID infection between January 2020 and September 1, 2021 (i.e., before home tests were widely available).\n\n   a. Clinical Criteria (Based on Council of State and Territorial Epidemiologists Standardized Surveillance Case Definition for COVID-19): i. At least two of the following symptoms: Fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s).\n\n   -OR- ii. At least one of the following symptoms: Cough, shortness of breath, or difficulty breathing.\n\n   -OR- iii. Severe respiratory illness with at least one of the following: clinical or radiographic evidence of pneumonia or Acute Respiratory Distress Syndrome (ARDS).\n\n   -AND- iv. No alternate more likely diagnosis\n4. Clinical evidence of Long COVID, as confirmed by the clinician's assessment:\n\n   a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).\n\n   i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory\u002Fconcentration (\"brain fog\"), headache, dysautonomia\u002Fpostural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell\u002Ftaste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.\n\n   b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.\n\n   c. Symptoms must be reported to have an impact on quality of life and\u002For everyday functioning and to be at least somewhat bothersome.\n\n   d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this investigation:\n\n1. Qualifying Long COVID symptoms cannot be explained by an infection-associated chronic condition diagnosed prior to the onset of Long COVID (e.g., ME\u002FCFS or other infection-associated chronic condition).\n2. Pre-existing cognitive impairment not exacerbated by COVID-19, including but not limited to syphilis, as determined by study clinicians (MD, DO, NP, PA, RN, or equivalent), which may include a review of participant's history and medical records.\n3. Severe cognitive, physical, or psychological disability preventing participation in the study, as determined by the investigator.\n4. Moderate or High risk of suicidality, as determined by the modified Columbia Suicide Severity Rating Scale (mC-SSRS).\n5. History of a major adverse cardiovascular event (MACE) within the 3 months prior to enrollment.\n6. Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs); however, DMARDs with minimal immunomodulatory effects (hydroxychloroquine, i.e., Plaquenil, steroids used for less than 2 weeks, minocycline), are not exclusionary.\n7. Known prior allergic reactions to components of the baricitinib.\n8. Previously randomized in this study or in the last 30 days have been in another study investigating baricitinib.\n9. Positive SARS-CoV-2 NAAT or rapid Antigen test in the 14 days prior to screening.\n10. Venous thromboembolism in the past 6 months prior to screening or felt to be at increased risk of thrombosis by the investigator.\n11. Malignancy or lymphoproliferative disorder not in remission for at least 5 years. Local non-melanoma skin cancers that are definitively managed are not exclusionary.\n12. Previous admission to an ICU for treatment of acute COVID-19 infection.\n13. Estimated glomerular filtration rate of \\\u003C 30 mL\u002Fmin\u002F1.73m2, as calculated using the CKD-EPI 2021 equation.\n14. Absolute Neutrophil Count (ANC) \\\u003C1000 cells\u002Fmm3, confirmed on repeat testing.\n15. Absolute Leukocyte Count (ALC) \\\u003C100 cells\u002Fmm3.\n16. Evidence of severe liver disease at the time of screening, defined as Bilirubin \\> 1.5 X ULN or AST or ALT \\> 2x ULN.\n17. Alkaline Phosphatase (ALP) ≥ 3x ULN.\n18. Creatine Phosphokinase (CPK) ≥ 3x ULN.\n19. Hemoglobin (HgB) \\\u003C 8 g\u002FdL, confirmed on repeat testing.\n20. Platelets \\\u003C100,000 cells\u002Fmm3, confirmed on repeat testing.\n21. Platelets \\>500,000 cells\u002Fmm3, confirmed on repeat testing.\n22. Total fasting cholesterol ≥ 280 mg\u002FdL, confirmed on repeat testing.\n23. Fasting LDL ≥ 180 mg\u002FdL, confirmed on repeat testing.\n24. Positive Hepatitis B surface antigen or Hepatitis B core antibody. Note: Individuals with a positive Hepatitis B core antibody will be excluded even in the presence of a positive Hepatitis B surface antibody due to the risk of reactivation.\n25. Positive for Hepatitis C at the time of Screening. Note: treated or cleared Hepatitis C is not exclusionary.\n26. Symptomatic herpes zoster infection (i.e., visible herpetic skin lesions of Zoster) within 3 months prior to study screening, or any history of disseminated\u002Fcomplicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis).\n27. History of untreated latent tuberculosis infection (diagnosed with QuantiFERON-TB Gold Plus testing) or active tuberculosis whether treated or untreated. Note: those with a positive PPD who have a history of BCG vaccine and a negative QuantiFERON-TB Gold Plus test will remain eligible).\n28. History of current or recent (\\\u003C 30 days from screening) sepsis or clinically significant viral, bacterial, fungal, or parasitic infection, according to the determination of the investigator.\n29. Participants with HIV will be excluded if they have been on ART \\\u003C1 year, have a CD4+ T cell count \\\u003C500 cells\u002Fml (confirmed on repeat), or have two consecutive HIV plasma RNA viral load \\> 48 copies\u002FmL within 1 year of study screening, including requiring the most recent within 3 months of screening. Blips (VL \\> 48 copies\u002FmL but \\\u003C 200 copies\u002FmL) are permitted if preceded and followed by values below the assay limit of quantification.\n30. Immunocompromised as defined by NIH COVID-19 guidelines (see Appendix) and, in the opinion of the investigator, at an unacceptable risk for participating in the study.\n31. Treatment with another investigational drug or device as part of an interventional study within 30 days of study screening.\n32. In the opinion of the investigator, unable to reliably follow-up for the duration of the study and\u002For are unable to follow study restrictions\u002Fprocedures.\n33. Persons of childbearing potential under age 55 who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening though at least 28 days after the end of the study intervention period. Note: Acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), other contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about risks related to pregnancy or breastfeeding.\n34. Currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study.\n35. Participants actively breastfeeding, who are unwilling to stop breastfeeding for the duration of the trial.\n36. Currently incarcerated\n\nNOTE RE: History of major adverse cardiovascular event (MACE) or traditional risk factors including smoking. For REVERSE-LC, MACE is defined as acute myocardial infarction and stroke. The study team will discuss the risks and benefits of baricitinib and CV events with the participant prior to study entry.\n\nNOTE RE: EBV\u002FCMV Seropositivity - The investigators will not exclude participants based on EBV or CMV seropositivity. The investigators already know that serologic evidence suggesting recent EBV reactivation is associated with Long COVID fatigue and high level EBV responses are associated with neurocognitive Long COVID, but that EBV viremia and IgM is rare. The investigators believe there is equipoise with regard to the potential effects of baricitinib on EBV - it is as likely that inflammation drives EBV reactivation, just as EBV can drive inflammation. For this reason, the investigators think this is best studied as a biological factor correlated with outcomes and that the investigators should not deliberately include or exclude people based on this. CMV seropositivity is associated with improved Long COVID outcomes. Results are not required for screening.",{"count":360,"type":23},550,[74],"The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.",[364,365,319,29],"Long COVID","Sars-CoV-2 Infection",[29,367,364],"Long COVID Drug Treatment","2026-05-07",{"date":370,"type":42},"2026-05-11",{"date":372,"type":42},"2024-10-21",{"date":374,"type":23},"2027-07-01",{"name":376,"class":196},"Wes Ely",17,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":387,"conditions":388,"keywords":391,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":147},"100445320","vaccine-responses-to-sars-cov-2-and-other-emerging-infectious-diseases-100445320","NCT05078905","Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases","Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases","* INCLUSION CRITERIA:\n\nGeneral Inclusion Criteria for All Groups:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Age 18 years or older\n3. Hemoglobin \\>= 9.0 grams per deciliter (g\u002FdL) or \\>= 11.2 for women who are pregnant.\n4. Willingness to give consent for the storage of blood samples for research\n5. Ability of subject to understand and the willingness to sign a written informed consent document\n\nInclusion Criteria for Primary (New) Vaccination Group:\n\n1\\. No history of having received a dose of the vaccine for the infectious disease being studied. Subjects who have enrolled under another Laboratory of Immunoregulation (LIR) protocol and had samples drawn prior to vaccination will also be eligible for enrollment.\n\nInclusion Criteria for Secondary (Booster) Vaccination Group:\n\n1\\. Willingness to return for baseline research blood collection prior to booster vaccination.\n\nEXCLUSION CRITERIA:\n\n1. Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.\n2. Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.",{"count":386,"type":23},1200,"Background:\n\nVaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why.\n\nObjective:\n\nTo learn more about how the immune system responds to vaccines against infections like SARS-CoV-2.\n\nEligibility:\n\nHealthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection.\n\nDesign:\n\nParticipants will be screened with a medical history and blood and urine tests.\n\nParticipants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health.\n\nAfter the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH.\n\nThis study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines.\n\n...",[29,389,390],"Vaccination","Healthy Volunteer",[389,392,29,393,394,241],"Pandemic","Pathogens","Immune Response",{"date":396,"type":42},"2026-05-08",{"date":398,"type":42},"2021-10-13",{"date":400,"type":23},"2050-01-01",{"name":48,"class":49},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":17,"sex":408,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":147},"100454444","the-impact-of-covid-19-on-maternal-and-neonatal-outcomes-100454444","NCT05197621","The Impact of COVID-19 on Maternal and Neonatal Outcomes","Inclusion Criteria for Vaccine Arm:\n\n* All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and\u002For a third dose booster during their pregnancy.\n\nExclusion Criteria:\n\n* Prior COVID-19 infection.\n\nInclusion Criteria for Sample Collection Arm:\n\n* All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment.\n* Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor \\& Delivery.\n\nExclusion Criteria:\n\n* None","FEMALE","14 Years","55 Years",{"count":184,"type":23},"The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection.\n\nThe FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.",[29,414],"Pregnancy; Infection","2026-05-06",{"date":370,"type":42},{"date":418,"type":42},"2020-04-13",{"date":420,"type":23},"2028-05-05",{"name":422,"class":196},"Johns Hopkins University",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":147},"100516620","a-study-of-post-covid-19-mechanisms-for-chronic-lung-sequelae-100516620","NCT06006884","A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae","Uncover Mechanisms Underlying the Development of Chronic Lung Sequelae Post COVID-19","Inclusion Criteria:\n\nFor the Sequelae Group\n\n* Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.\n* Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).\n\nControl Recovery Group\n\n* Age ≥18 years at screening\n* PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization 7,48,49\n* Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.\n\nExclusion Criteria:\n\n* Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease;\n* Active cigarette smoking, vaping or other inhalation use.\n* Immunocompromised host status due to ongoing therapy with methotrexate, CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents;\n* \\> 20 pack year smoking history.\n* History of chemotherapy or radiation therapy in the last two years; and pregnancy.",{"count":431,"type":23},67,"The purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection",[29],[29,84,364,435,436],"chronic lung sequelae","post-acute","2026-05-01",{"date":368,"type":42},{"date":440,"type":42},"2024-01-10",{"date":442,"type":23},"2027-08",{"name":444,"class":196},"Mayo Clinic",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":455,"studyType":137,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":300},"100453751","international-survey-of-acute-coronavirus-syndromes-covid-19-100453751","NCT05188612","International Survey of Acute Coronavirus Syndromes-COVID-19","International Survey of Acute Coronavirus Syndromes (ISACS)-COVID-19","ISACS-COVID-19","Inclusion Criteria:\n\n* Age ≥18 years (male or female)\n* Patients admitted to any hospital center with a confirmed diagnosis of COVID-19 infection.\n\nExclusion Criteria:\n\n• Underage or not able to give informed consent",{"count":454,"type":23},10000,"1 Year","In response to the COVID-19 crisis, ISACS-TC has promoted a new registry of the existing and further centers of the same geographic areas to support clinical research to prevent, and treat the COVID-19 illness. These efforts are made possible by the generous contributions of clinical research volunteers in some of the countries participating to the prior acute coronary syndrome network.",[29],"2026-04-27",{"date":437,"type":42},{"date":461,"type":42},"2021-12-01",{"date":463,"type":23},"2026-12-31",{"name":465,"class":196},"University of Bologna",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":147},"100387882","impact-of-the-coronavirus-covid-19-on-patients-with-cancer-100387882","NCT04330521","Impact of the Coronavirus (COVID-19) on Patients With Cancer","Inclusion Criteria:\n\n1. The patients must be 18 years or older.\n2. Patients who opt in to complete the survey.\n3. Patients must have the capacity to verbally consent for the interview.\n\nExclusion Criteria:\n\n1.Patients who under the age of 18 years old.","99 Years",{"count":474,"type":23},50,"The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.",[477,29],"Cancer",[85,29,477,479],"Life Change Events","2026-04-24",{"date":458,"type":42},{"date":483,"type":42},"2020-04-08",{"date":297,"type":23},{"name":486,"class":196},"Stanford University",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":147},"100633472","c11-er176-pet-in-evaluating-neuroinflammation-in-patients-with-post-covid-syndrome-100633472","NCT07527130","C11 ER176 PET in Evaluating Neuroinflammation in Patients With Post-COVID Syndrome","Inclusion Criteria:\n\n* Mayo Clinic patients with a previously confirmed infection with the novel SARS-CoV-2 virus who have been seen in the Post COVID Clinic through GIM Integrative Medicine \\& Health Section or approval by MAGPIES research group.\n* Be able to participate fully in all aspects of the study.\n* Have understood and signed study informed consent.\n\nExclusion Criteria:\n\n* Lacking the capacity to consent.\n* Prisoners and institutionalized individuals.\n* Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the LLLT treatment phase and are unwilling to use a reliable form of contraception.\n\n  o Acceptable forms include:\n  * Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants\n  * Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)\n  * Intrauterine device (IUD)\n  * Total hysterectomy or tubal ligation\n  * Abstinence (no sex).\n* Those patients that have implants that would prevent them from having a PET Scan.\n* Patients that have claustrophobia.\n* Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.",{"count":494,"type":23},10,"The purpose of this research is to find out if Positron Emission Tomography (PET) imaging with an investigational drug called C-11 ER176 can help us learn more about Post-COVID Syndrome.",[29],"2026-04-21",{"date":480,"type":42},{"date":500,"type":23},"2026-05",{"date":297,"type":23},{"name":444,"class":196},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":511,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":147},"100504976","phase-2-arginine-replacement-therapy-in-covid-19-100504976","NCT05855330","Arginine Replacement Therapy in COVID-19","Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19","ART-COVID19","Inclusion Criteria:\n\n* Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection\n* Age 3 years - 21 years of age\n\nExclusion Criteria:\n\n* Severe hepatic dysfunction: ALT\\> 6 x Upper limit of normal\n* Renal dysfunction: Creatinine \\> 1.5 x upper limit of normal or on dialysis\n* Acute Stroke\n* Pregnancy\n* Allergy to arginine\n* Past history of severe cardiac disease or significant cardiac surgery \\[minor procedures like ventricular septal defect (VSD) repair are not an exclusion\\]\n* History of significant pulmonary disease \\[Cystic Fibrosis, sickle cell disease (SCD)\\]\n* History of organ transplant\n* History of metabolic or mitochondrial disease (including Diabetes)\n* History of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury)\n* History of ventriculoperitoneal (VP) shunt or hydrocephalus\n* PI discretion that the patient is not an ideal candidate for the study\n* History of HIV of immune compromise","3 Years","21 Years",{"count":514,"type":23},21,[108],"This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19.\n\nThe study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.",[29],"2026-04-10",{"date":520,"type":42},"2026-04-15",{"date":522,"type":42},"2024-01-08",{"date":220,"type":23},{"name":525,"class":196},"Emory University",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":24,"phases":536,"briefSummary":537,"conditions":538,"keywords":544,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":147},"100583051","evaluating-the-impact-of-a-functional-and-cognitive-strategy-in-patients-with-long-covid-19-100583051","NCT06871293","Evaluating the Impact of a Functional and Cognitive Strategy in Patients With Long Covid-19","Impact of Functional and Cognitive Rehabilitation, in Adults With Chronic Noncommunicable Diseases and Long Covid-19 , on Their Functional and Cognitive Capacity, Quality of Life, and the Evolution of Their Baseline Condition, in Bogotá D.C.","Inclusion Criteria:\n\n* Covid-19 confirmed.\n* History of arterial hypertension or diabetes mellitus before entering the institutional registries of the FCI-IC or HOMIL, institutional registries of the FCI-IC or HOMIL or before having the diagnosis of SARSCoV-2 infection.\n* Persistence of two or more concurrent symptoms, related to Covid-19 prologue, for at least 4 weeks (persistent, intermittent, or intermittent).\n* At least one of these symptoms must have an impact on activities of daily living. They can be physical (fatigue, dyspnea, myalgias, arthralgias) or neuropsychiatric (cognitive, sleep and emotional alterations).\n* Symptoms unexplained by underlying disease or other condition concomitant with SARS-CoV-2 infection. SARS-CoV-2 infection (determined by prior medical history review and participant interview).\n\nparticipant interview).\n\n\\- Ability to read and attend functional and cognitive rehabilitation sessions or to receive the with evidence-based informational messages.\n\nExclusion Criteria:\n\n* Age \\>80 years.\n* Severely advanced baseline comorbidities prior to SARS-CoV-2 infection.\n* Presence of chronic respiratory disease (partial or permanent supplemental oxygen use), cardiac failure (LVEF\\\u003C40%) or advanced renal disease (GFR\\\u003C30%).\n\nheart failure (LVEF\\\u003C40%) or advanced renal disease (GFR\\\u003C30).\n\n* Two hospitalizations in the year prior to admission to the institutional registries of the FCI-IC and the HOMIL for the patient's underlying disease.\n* Dependence on a caregiver.\n* Orthopedic or cardiopulmonary problems that contraindicate the performance of aerobic exercise.\n* Neuropsychiatric or cognitive limitations that limit understanding or following commands and performing attention exercises.","80 Years",{"count":535,"type":23},374,[207],"This study aims to evaluate the impact of a functional and cognitive rehabilitation strategy compared to evidence-based informational messages, on functional capacity, cognitive abilities, quality of life, and disease progression in adults with chronic non-communicable diseases (NCDs) and Long Covid-19.\n\nResearchers will compare a structured rehabilitation program to informational support through evidence-based messages to determine if rehabilitation leads to better functional and cognitive outcomes in patients with Long Covid-19.\n\nParticipants will be randomly assigned to one of two groups:\n\n1. Functional and cognitive rehabilitation: Attending weekly in-person sessions for 8 weeks, including supervised physical and cognitive exercises.\n2. Informational support: Receiving weekly evidence-based educational messages for 8 weeks.\n\nParticipants will undergo assessments at baseline, post-intervention, and six months later, including a six-minute walk test, handgrip strength measurement, and questionnaires on disability, anxiety, depression, fatigue, dyspnea, cognitive function, and quality of life.",[539,540,541,542,543,364],"Long COVID-19 Syndrome","COVID 19","Noncommunicable Disease","Hypertension","Diabetes Mellitus",[545,546,547,548,542,543,549,550],"Covid 19","Sars CoV 2","Post-acute Covid-19 syndrome","Long Covid","Noncommunicable disease","Rehabilitation","2026-04-08",{"date":553,"type":42},"2026-04-13",{"date":555,"type":42},"2025-10-30",{"date":557,"type":23},"2027-01-01",{"name":559,"class":196},"Fundación Cardioinfantil Instituto de Cardiología",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":511,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":568,"conditions":569,"keywords":571,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":300},"100459715","respiratory-virus-sampling-and-repository-100459715","NCT05266222","Respiratory Virus Sampling and Repository","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged 3 years or older.\n2. Documented or suspected infection with a respiratory virus.\n3. Stated willingness to comply with all study procedures for the duration of the study.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.\n\nNon-English Speaking Participants: This study will enroll non-English speaking participants.\n\nFor non-English speaking participants, the study will be explained to the participant\u002Ffamily through an interpreter, in the presence of the study team, in the language understood by the participant\u002Ffamily. The short form in the language understood by the participant\u002Ffamily will be signed by the participant\u002Ffamily or LAR and the interpreter, and the consent will be signed by the consenting provider and the interpreter.",{"count":567,"type":23},20000,"Background:\n\nRespiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus infections. The samples in this natural history study will be used in future research.\n\nObjective:\n\nTo obtain samples from people with respiratory viruses to learn more about respiratory virus infections and the immune responses against them.\n\nEligibility:\n\nPeople aged 3 and older who have or are suspected to have a respiratory virus infection.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will give blood samples. Data from their medical records will be collected.\n\nParticipants will give nose samples. A soft plastic strip will be put into each nostril for a minute. They may also give nose, mouth (back of the throat), or saliva samples using swabs.\n\nParticipants may receive kits by mail to collect nose and blood samples at home. They will use soft plastic strips to collect nose samples. To collect blood, they will prick their finger and dab a few drops of blood on four plastic tips.\n\nIf a participant is in the hospital, air samples may be collected in their room.\n\nParticipation will last for up to 2 years. After 2 years, participants may be asked for their consent again to give new samples and new medical data.",[570,29],"Influenza",[570,572,32,85,573,241],"Flu","Immunity","2026-04-07",{"date":551,"type":42},{"date":577,"type":42},"2022-08-11",{"date":579,"type":23},"2031-12-31",{"name":48,"class":49},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":230,"enrollmentInfo":587,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":147},"100423513","natural-history-of-systemic-and-nasal-mucosal-immunity-to-influenza-and-sars-cov-2-in-adults-after-vaccination-100423513","NCT04794829","Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. NIH staff members, at the time of enrollment.\n2. Able to provide informed consent.\n3. \\>=18 years of age.\n4. Planning to receive the current influenza season s vaccine and\u002For an FDA-authorized or approved SARS-CoV-2 vaccine.\n5. Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.\n6. Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Already received the current season s influenza vaccine and does not plan to receive an FDA-authorized or approved SARS CoV-2 vaccine.\n2. Already received an FDA-authorized or approved SARS-CoV-2 vaccine and does not plan to receive the current season s influenza vaccine.\n3. Not willing to receive the current influenza season's vaccine and not willing to receive an FDA-authorized or approved SARS-CoV-2 vaccine.\n4. Any condition that, in the opinion of the investigator, contraindicates participation in this study.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.",{"count":588,"type":23},150,"Background:\n\nInfluenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and\u002For COVID-19 vaccine.\n\nObjective:\n\nTo understand what happens to the body s immune system throughout the year after getting the flu and\u002For COVID-19 vaccine.\n\nEligibility:\n\nAdults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and\u002For COVID-19 vaccine.\n\nDesign:\n\nParticipants will not get any vaccines as part of this study.\n\nParticipants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations.\n\nParticipants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended.\n\nOnce a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history.\n\nOnce a month, participants will have blood drawn.\n\nOnce a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute.\n\nParticipants may be able to collect samples at home and mail them to NIH if they are not able to visit in person.\n\nParticipation will last for about 12 13 months.",[570,29],[572,592,593,392,29,241],"Antibody","Immunization",{"date":551,"type":42},{"date":596,"type":42},"2021-08-19",{"date":463,"type":23},{"name":48,"class":49},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":455,"studyType":137,"phases":4,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":147},"100390739","armor-study-covid-19-seroprevalence-among-healthcare-workers-100390739","NCT04367857","ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers","SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project","Inclusion Criteria:\n\n* 18 years of age or older\n* NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate\n* Understands and reads English\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* Mentally and\u002For physically unable to complete study requirements",{"count":232,"type":23},"The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.",[609,610,85],"Covid-19","Coronavirus Infection","2026-04-03",{"date":551,"type":42},{"date":614,"type":42},"2020-04-18",{"date":616,"type":23},"2027-02",{"name":618,"class":196},"Columbia University"]