[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100627233","phase-1-a-study-evaluating-mdx2301-in-healthy-adults-and-adults-at-higher-risk-for-severe-covid-19-100627233",false,"NCT07445971","A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.","A Phase 1a\u002Fb Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19","Inclusion Criteria\n\nHealthy Adults\n\n1. Participant is a healthy male or female, 18 to 64 years of age.\n2. Participant is in good health in the opinion of the investigator.\n\n   Adults at Higher Risk for Developing Severe COVID-19:\n3. Participant is a male or female, 18 to 64 years of age.\n4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:\n\n   1. Asthma\n   2. Diabetes\n   3. Cerebrovascular disease, which affects blood flow to the brain.\n   4. Chronic kidney disease\n   5. Chronic lung disease\n   6. Cardiac disease\n   7. Chronic liver disease\n   8. Cystic fibrosis\n   9. HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening.\n   10. Sickle cell disease or thalassemia\n5. Participant is clinically stable with no clinically significant abnormalities.\n6. Participant has not been hospitalized within the 12 months prior to screening or is not expected to be hospitalized during the study due to underlying medical conditions.\n\n   All Participants\n7. Female participants of childbearing potential must have a negative urine pregnancy test.\n8. Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method.\n9. Participant is able to understand and sign the informed consent form prior to undergoing any study procedures.\n10. Participant is willing and able to comply with scheduled visits and procedures.\n\nExclusion Criteria:\n\nHealthy Adults\n\n1. Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.\n2. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.\n\n   Adults at Higher Risk for Severe COVID-19:\n3. Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.\n4. Participant has evidence of active hepatitis B or hepatitis C infections at screening.\n\n   All Participants\n5. Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1.\n6. Participant tests positive for SARS-CoV-2 infection at screening.\n7. Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1.\n8. Participant has received a SARS-CoV-2 vaccine prior to dosing.\n9. Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1.\n10. Participant has received or is expected to receive for the duration of the study immunoglobulin, blood-derived products, high-dose systemic corticosteroids, or other immunosuppressant drugs within 6 months prior to Day 1.\n11. Participant is pregnant, breastfeeding, or seeking pregnancy while on the study.\n12. Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection.\n13. Participant had major surgery within 30 days prior to Day 1.\n14. Participant has donated blood prior to screening.\n15. Participant has any skin condition and\u002For tattoo that may interfere with the evaluation of safety at the injection site.\n16. Participant has a history of alcoholism or illicit drug use prior to screening or a positive test for drugs of abuse at screening or on Day -1.\n17. Participant is a current smoker or user of other nicotine containing products on a daily basis.\n18. Participant has received an investigational product within 30 days prior to Day 1.\n19. Participant has a known hypersensitivity to any components of MDX2301, any of its excipients or closely related compounds.\n\n    For All Participants, Temporary Exclusions for Randomization on Day 1 if Remains within the Screening Window:\n20. Participant has any acute illness, within 3 days of Day 1.\n21. Participant has vital signs considered by the investigator to be clinically significant prior to study drug administration.\n22. Participant has had close contact with anyone confirmed to have SARS-CoV-2 infection within the 7 days prior to Day 1.\n23. Any acute drug therapy prescribed by a physician within 7 days prior to Day 1.",true,"ALL","18 Years","64 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.",[28,29],"COVID -19","COVID-19 (Prevention)","RECRUITING","2026-05-15",{"date":33,"type":34},"2026-05-18","ACTUAL",{"date":36,"type":34},"2026-03-24",{"date":38,"type":22},"2027-12",{"name":40,"class":41},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100616183","analysis-of-suicidal-behavior-among-children-and-adolescents-in-the-auvergne-rhone-alpes-region-during-the-covid-19-pandemic-period-100616183","NCT07302295","Analysis of Suicidal Behavior Among Children and Adolescents in the Auvergne-Rhone-Alpes Region During the Covid 19 Pandemic Period","Clinical and Socioeconomic Characteristics of Suicidal Behaviour in Children and Adolescents During the Covid19 Pandemic Period in Auvergne-Rhône-Alpes. Prospective Quantitative and Qualitative Study","TSPedCovid","Inclusion Criteria:\n\n* The population (subjects and controls) will be divided into age categories:\n\n  * Pre-adolescents (≥ 8 years and \\\u003C 11 years)\n  * Adolescents (≥ 11 years and \\\u003C 15 years)\n  * Older adolescents (≥ 15 years and \\\u003C 18 years)\n\nSubjects with suicidal behavior during the health crisis (Group 1):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2020 to 2022.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and\u002For 2022 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n\nSubjects with suicidal behavior during the health crisis with qualitative interviews (Group 1b):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2020 to 2022.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2020, 2021, and\u002For 2022 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n* Randomly selected from the population of Group 1.\n* For whom the parent(s) and\u002For the subject have signed informed consent.\n\nControls with suicidal behavior before the health crisis (Group 2):\n\n* Age \\> 8 years and \\\u003C 18 years during the period 2018 to 2019.\n* Admitted to pediatric emergency departments or hospitalized in a care unit (CHU, general hospitals) in the AURA region during 2018 and\u002For 2019 for suicidal behavior (defined as suicidal ideation and\u002For suicide attempt and\u002For self-harm\u002Fself-poisoning with suicidal intent).\n\nExclusion Criteria:\n\n\\- Subjects with Suicidal Behavior during the Health Crisis with and without Qualitative Interviews (Group 1 and 1b):\n\n• Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2020 to 2022.\n\nControls with Suicidal Behavior before the Health Crisis (Group 2):\n\n* Admitted to pediatric emergency services or hospitalized in a healthcare facility (university hospital center, general hospital) in the AURA region for a psychiatric reason other than suicidal behavior during the period from 2018 to 2019.\n* Intercurrent illness with a life expectancy of less than 24 hours.\n\nFor Group 1:\n\n* Pregnant, postpartum, or breastfeeding women.\n* Persons deprived of liberty by judicial or administrative decision.\n* Adults subject to a legal protection measure (guardianship, curatorship).\n* Persons not affiliated with a social security scheme or beneficiaries of a similar scheme.\n* Persons who do not understand and do not speak French.","8 Years",{"count":53,"type":22},6500,[55],"NA","In 2020, the world is hit by a global health crisis due to a pandemic following the appearance of Sars-cov-2 or \"covid-19\". This pandemic was accompanied by a constant fear of contamination and death, relayed by the media. In France, the government proposed in response to the arrival of this virus on French territory. This policy was implemented in different ways over 3 distinct periods: strict containment at the start of the epidemic, then a \"lighter\" one, and finally a period of social restrictions without between these periods. This policy had a direct and rapid impact on the population's daily routines. Children and adolescents, are more susceptible to psychological trauma, as stress has a direct and psychic development. Studies have shown deleterious impact of the French health situation on the paediatric population. They point to an increase of psychological disorders such as depression and anxiety in the under -20s population, and an increase in suicidal gestures over the 2020-2021 period, with rates remaining higher than in previous years. Suicide is the 2nd leading cause of death in the population aged 15-24.\n\nStudies continue to focus on the incidence of suicidal gestures of suicidal gestures and psychological disorders, and few of them examine the factors linked to the increase in these incidences, the traumatic impact or the story of the trajectory. Similarly, the few studies focus only on the population aged 12 and over, and in some cases, do not distinguish between age groups (15-24 or under 20).\n\nInvestigators believe that the various periods of social restrictions and eco-anxiety caused by the pandemic may have influenced suicidal behaviour in this population.\n\nThe main objective of this study is to investigate the clinical and socio-economic characteristics of the pediatric population who experienced suicidal behaviors in the Auvergne Rhone Alpes region during the covid 19 pandemic.",[58,28],"Suicidality",[60,61,62],"suicide","pediatrics","covid-19",{"date":33,"type":34},{"date":65,"type":34},"2026-05-06",{"date":67,"type":22},"2028-02",{"name":69,"class":70},"Hospices Civils de Lyon","OTHER",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":81,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":42},"100604284","preparedness-through-respiratory-virus-epidemiology-and-community-engagement-100604284","NCT07147517","Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT: Preparedness Through Respiratory Virus Epidemiology and Community Engagement","PREVENT","Community Testing Component:\n\nInclusion:\n\n\\- All community members are able to participate in the community testing component.\n\nExclusion:\n\n\\- There is no exclusion criteria and participants will not be excluded based on pregnancy status or age.\n\nFor Component A:\n\nInclusion:\n\n* All ages\n* AND Lives in service area of a recruitment center (i.e., within range of courier pick up)\n* AND Plans to remain living in a recruitment area for the next 2 years.\n\nExclusion:\n\n* Inability to communicate in a language in which consent forms, materials, etc. are available\n* OR Incarcerated\n* OR Living in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* OR Unable\u002Funwilling to participate in planned data and specimen collections\n* OR Unable to comply with study procedures, as determined by study investigators\n* OR Participation in clinical trials of investigational agents for respiratory viral infections during the three months prior to enrollment and for the duration of the study.\n\nFor Component B:\n\nInclusion:\n\nIndex case:\n\n* Detection of priority respiratory pathogen via laboratory or point-of-care test on the day of eligibility screening or in the previous 5 days, AND\n* Lives in service area of a recruitment center (i.e., within range of courier pick up), AND\n* Lives in a household with ≥1 other person and plans to remain in the household for at least the duration of specimen collection (i.e., 14 days), AND\n* Has not been hospitalized since the date of symptom onset.\n\nHousehold contacts:\n\n* Routinely sleep in the same household as index case and slept in household ≥1 night in the 7 days before index case symptom onset, AND\n* Plan to remain in the household for at least the duration of specimen collection (i.e., 14 days).\n\nHousehold:\n\n* There is ≥1 non-ill household member (i.e., asymptomatic and has not tested positive for the virus of the index case) on the day of eligibility screening or in the previous 5 days,\n* AND all symptomatic persons in the household had a symptom or diagnosis onset date on the day of eligibility screening or in the previous 5 days.\n\nExclusion:\n\nIndex case:\n\n* Lives in a congregate setting (e.g., assisted living, nursing home, university dormitories with shared bathroom and communal eating facilities)\n* Meet any A1 exclusion criteria\n\nHousehold contacts:\n\n* Has been hospitalized any time since date of primary case symptom onset\n* Meets any A1 exclusion criteria\n\nHousehold:\n\n* The enrollment visit occurs \\>6 days after the first symptom onset of primary case\n* The primary case in the household is not enrolled\n* The primary case has been hospitalized any time after the date of symptom onset",{"count":80,"type":22},25000,"5 Years","OBSERVATIONAL","The CHARM network will be established through three primary institutions-Beth Israel Deaconess Medical Center (BIDMC), the University of California San Diego (UCSD), and the University of Washington (UW)-along with their subcontracting institutions. At UCSD and partner sites, the CHARM network will be implemented via the PREVENT project. All PREVENT participants will be consented in to Component A0 (Community Testing) and a subset of A0 participants will be invited to participate and will be consented into the other components: Component A (Ongoing Testing); Component A Sub-study (Immunology); Component B (Household Transmission).\n\nComponent A0 participants (Community testing) will be members of the community who are interested in accessing testing for respiratory infections and will be asked to provide limited information that will then be used for screening for study Components A and\u002For B.\n\nParticipants in Component A (Ongoing Testing ) will undergo weekly symptom screening. If they report symptoms, they will be asked to provide a nasal swab and complete illness questionnaires on the day they report symptoms (Day 0) and again on Days 7 and 14. Participants in Component A Sub-study (Immunology) will provide blood and saliva\u002Fnasal fluid samples twice a year, as well as before and after infection and\u002For immunization against priority pathogens.\n\nParticipants in Component B (Household Transmission) will complete daily symptom questionnaires and nasal swabs for 14 days following enrollment, regardless of symptoms. Those who are symptomatic at enrollment will also complete retrospective daily diaries from symptom onset to the enrollment date. Additionally, they provide blood and\u002For saliva\u002Fnasal fluid samples at enrollment and again 28 days later.\n\nFor all Components, UCSD will provide PCR test results for SARS-CoV-2, Influenza A\u002FB, and RSV for nasal swab samples.",[85,28,86,87],"Respiratory Infection Virus","RSV","FLU",[89,90,91],"respiratory pathogen testing","vending machine","implementation","2025-10-31",{"date":94,"type":34},"2025-11-04",{"date":96,"type":34},"2025-10-08",{"date":98,"type":22},"2030-10-30",{"name":100,"class":70},"University of California, San Diego",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100609673","clinical-validation-of-the-aptitude-medical-systems-metrix-respiratory-panel-test-in-at-homenon-laboratory-settings-100609673","NCT07217639","Clinical Validation of the Aptitude Medical Systems Metrix Respiratory Panel Test in At-Home\u002FNon-Laboratory Settings","Inclusion Criteria:\n\n1. Participant or guardian understands and is able and willing to provide written informed consent, and assent where applicable, prior to study enrollment.\n2. Participant is currently exhibiting signs\u002Fsymptoms of respiratory tract infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, new loss of taste or smell, or fatigue. Participant must still be exhibiting symptoms on the day of specimen collection. Days post symptom onset is not to exceed 14 days.\n3. Participant or guardian agrees to read, and is able to read with understanding, the Quick Reference Instructions (QRI) prior to beginning the execution of each of the tests.\n4. Participant or guardian is able and willing to contribute the required swab specimens for testing and understands and is able and willing to sign the study informed consent.\n5. Participant is willing to provide all samples and run tests for the specified investigational devices.\n\nExclusion Criteria:\n\n1. Participant does not understand and\u002For is not able and willing to sign the study informed consent and\u002For assent.\n2. Participant or guardian is not able to comply with nasal swab collection requirements following the Quick Reference Instructions (QRI).\n3. Participant is not currently exhibiting respiratory tract infection symptoms.\n4. Participant has previously participated in the study.\n5. Participant is not able to tolerate specimen collection.\n6. Participant is currently undergoing or has within the past thirty (30) days undergone treatment with prescription medication to treat SARS-CoV-2 infection, including but not limited to Remdesivir (Veklury®), Nirmatrelvir\u002FRitonavir (Paxlovid®), Molnupiravir (LagevrioTM) or receiving convalescent plasma therapy for SARS-CoV- 2.\n7. Participant is currently undergoing or has within the past thirty (30) days undergone an inhaled influenza vaccine (FluMist®), or antiviral treatment, including but not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), Baloxavir Marboxil (Xofluza®), Amantadine (Symmetrel®), Rimantadine (Flumadine®), or Peramivir (Rapivab®).\n8. Participant is currently undergoing or has within the past thirty (30) days undergone antiviral treatment for RSV, including but not limited to Ribavirin (Virazole®), RSV-IGIV (RespiGam®), Palivizumab (Synagis®), or Nirsevimab-alip (Beyfortus®).\n9. Participants who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.\n10. Participants who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months.\n11. Participants who do not understand\u002Fread the English language.",{"count":108,"type":22},2000,[55],"The Metrix Respiratory Panel Test will be evaluated for use in Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein. The study will take place in simulated home environments which will be set up within or near active clinical settings (e.g., urgent care facilities). This will be a prospective study conducted at three or more investigational sites located within the United States for the clinical validation of the Metrix Respiratory Panel Test for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory syncytial virus, and Rhinovirus in anterior nares (AN) swab samples. Additional sites may be added to the study in order to meet minimum subject\u002Fsample enrollment requirements and geographic prevalence of respiratory virus infections. Comparator testing will be performed to determine the infection status of each sample for comparison to results generated by the candidate test. The primary comparator for the study will be an FDA-cleared assay for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus, and Rhinovirus.",[28,112,113,114,86,115],"Influenza A","Influenza B","Respiratory Synctial Virus","Rhinovirus","NOT_YET_RECRUITING","2025-10-14",{"date":119,"type":34},"2025-10-16",{"date":121,"type":22},"2025-11-01",{"date":123,"type":22},"2026-09-01",{"name":125,"class":41},"Aptitude Medical Systems",1]