[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"influenza-human\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:influenza-human":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,63,87,109,137,165,185,211,242,271,298],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100568680","phase-1-study-on-safety-and-efficacy-of-two-doses-of-prs-ck-storm-in-the-modulation-of-the-cytokine-storm-in-patients-with-acute-respiratory-infection-caused-by-sars-cov-2-influenza-a-influenza-b-and-respiratory-syncytial-virus-rsv-100568680",false,"NCT06684379","Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Double-blind, Randomized, Placebo-controlled, Pilot Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Two Doses of a Conditioned Medium From a Co-culture of M2-macrophages and Fat-derived Mesenchymal Cells (PRS CK STORM) in the Modulation of the Cytokine Storm in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)","Inclusion Criteria:\n\n1. Signed informed consent by the participant or legal representative prior to the initiation of any study-specific procedure.\n2. Males and females aged ≥ 18 years old at the time of the consent.\n3. Confirmed diagnosis of SARS-CoV-2, influenza virus A, influenza virus B or RSV pneumonia by positive RT-PCR (results of a PCR prior to screening will be valid only if the PCR has been done for all 4 viruses and in 3 days prior to the screening visit). PCR will include the analysis of SARS-Cov-2, influenza A, influenza B and RSV.\n4. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:\n\n   1. Body temperature over 38 ºC or under 36 ºC.\n   2. Heart rate greater than 90 beats\u002Fminute.\n   3. Respiratory rate higher than 20 breaths\u002Fmin or PaCO2 lower than 32 mmHg.\n   4. Leukocyte count higher than 12000\u002FμL, lower than 4000\u002FμL or over 10% immature forms or bands.\n5. Need for oxygen therapy.\n6. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \\[FSH\\] more than 20 international units \\[Ius\\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \\[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration.\n\nExclusion Criteria:\n\n1. Failure to perform screening or baseline examinations.\n2. Body Mass Index (BMI) more than or equal to 35.\n3. Irreversible critical condition, as assessed by the investigator.\n4. Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.\n5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:\n\n   1. Liver function test abnormalities or other signs of hepatic insufficiency not justified by a pulmonary acute inflammation process: Aspartate transaminase (AST), alanine transaminase (ALT) more than 3 per upper limit of the reference range, total bilirubin more than or equal to 2 mg\u002FdL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome.\n   2. Renal insufficiency (serum creatinine more than 2 mg\u002FdL (more than 150 μmol\u002FL) and creatinine clearance less than 30 (according to Cockcroft-Gault formula).\n   3. Myocardial infarction, unstable angina, heart failure within 3 months before screening.\n   4. Bradycardia (heartbeat less than 50\u002Fmin).\n   5. Atrioventricular block (type II \u002F Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males more than 450 msec and females more than 470 msec using Fridericia's formula: QTc = QT\u002F RR\\^2 ).\n   6. Uncontrolled diabetes mellitus (blood glucose level above 500 mg\u002FdL) at the time of admission.\n   7. Malignant tumors within the last 5 years, unless stable during that time. Skin malignancies (other than melanoma) and indolent prostate cancer are excluded from this criterion.\n   8. Metastases.\n   9. Human Immunodeficiency Virus (HIV), HBV \\[hepatitis B surface antigen (HBs Ag) positive (+), or detected sensitivity on the HBV deoxyribonucleic acid (DNA), polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBc Ab) positive subjects\\] or HCV \\[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\\].\n6. Inability to comply with the study and monitoring procedures.\n7. Pregnant and breastfeeding females (pregnancy test positive).\n8. Suspected or known active drug or alcohol abuse.\n9. Enrollment in another investigational drug study within 1 month before the screening\n10. Subject who has any condition, including any psychological or psychiatric condition, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy.\n\nThe main questions it aims to answer are:\n\n* Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n* Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV compared to the control group?\n* What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?\n\nResearchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.",[27,28,29,30,31],"SARS-CoV-2","Influenza, Human","Respiratory Syncytial Virus Infections","Respiratory Distress Syndrome","Systemic Inflammatory Response Syndrome",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,31],"SARS-CoV-2 infection","Causing atypical respiratory disease (COVID-19)","2019 Novel Coronavirus","COVID-19 Virus","SARS Coronavirus 2","COVID-19-associated cytokine storm","Lung Diseases","Pneumonia","M2-macrophages","Mesenchymal cells","Influenza A Virus","Influenza B Virus","RSV Infection","Acute Respiratory Distress Syndrome","ARDS, Human","Respiratory Distress Syndrome, Acute","Cytokine storm","RECRUITING","2026-06-05",{"date":53,"type":54},"2026-06-10","ACTUAL",{"date":56,"type":54},"2024-10-02",{"date":58,"type":20},"2026-10-02",{"name":60,"class":61},"PEACHES BIOTECH","INDUSTRY",3,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100578172","flu-infection-at-uphs-100578172","NCT06807840","Flu Infection at UPHS","Evaluating Immune Imprinting in the Context of Influenza Virus Infections","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Aged 18 years and older\n4. Influenza positive test result performed within the University of Pennsylvania Health System\n\nExclusion Criteria:\n\n1. Known latex allergy\n2. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months\n3. Pregnancy due to the volume of blood collected in this study\n4. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study\n5. Any neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy (\"active\" is defined as having received treatment within the past 5 years)\n6. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would interfere with the evaluation of immune responses\n7. Intends to donate blood during the study period\n8. A known human immunodeficiency virus, hepatitis B, or hepatitis C infection\n9. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol\n10. Prolonged inpatient hospitalization that disrupts or interferes with study procedures.\n11. Weigh less than 110lbs",{"count":19,"type":20},"OBSERVATIONAL","Cellular and humoral immune responses in individuals with active influenza infection will be assessed. Each year, up to 50 participants will be enrolled. The investigators hypothesize that influenza infection will elicit mostly memory immune responses rather than de novo immune responses to infection.",[74],"Influenza Human",[67],"2026-06-02",{"date":78,"type":54},"2026-06-03",{"date":80,"type":54},"2025-01-27",{"date":82,"type":20},"2026-09-30",{"name":84,"class":85},"University of Pennsylvania","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":86},"100579455","phase-1-clinical-trials-of-quadrivalent-influenza-vaccine-100579455","NCT06824519","Clinical Trials of Quadrivalent Influenza Vaccine","A Randomized, Blinded Phase I.\u002FII Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant","Inclusion Criteria:\n\n1. When signing the informed consent form, be at least 18 years old and provide valid identification;\n2. The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves;\n3. On the day of enrollment, axillary temperature was ≤ 37.0 ℃;\n4. Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.\n\nExclusion Criteria:\n\n1. The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);\n2. Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);\n3. Previously or currently suffering from autoimmune or immunodeficiency diseases;\n4. Previous history of severe allergies to any vaccine\u002Fdrug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory distress, angioneurotic edema, or individuals with an allergic constitution (such as allergies to two or more drugs, food, or pollen); History of severe allergy to eggs or egg protein;\n5. Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and collecting blood samples);\n6. Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this trial) (before completing the immunization and collecting blood samples);\n7. The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days;\n8. Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness;\n9. Used antipyretic, analgesic, or anti allergic drugs within 3 days prior to enrollment;\n10. Use immunoglobulin and\u002For any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing immunization and collecting blood samples);\n11. Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of ≥ 0.5 mg\u002Fkg\u002Fday (inhalation and local steroid hormones are not restricted);\n12. Absence of spleen, functional absence of spleen, and splenectomy caused by any condition;\n13. Any obvious coagulation dysfunction or history of anticoagulant therapy;\n14. History of epilepsy, encephalopathy, and malignant tumors;\n15. Suffering from serious cardiovascular system diseases, serious hypertension with unstable drugs (systolic pressure ≥ 160mmHg and\u002For diastolic pressure ≥ 100mmHg), diabetes with serious complications and other serious chronic diseases;\n16. Currently suffering from respiratory system diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute liver and kidney diseases (severe impairment of liver and kidney function), mental disorders (such as schizophrenia, depression, affective disorders, etc.), etc;\n17. Women of childbearing age who are breastfeeding, pregnant, or have a positive urine pregnancy test before enrollment;\n18. Plan to move out of the local area before the end of the study or plan to leave the local area for a long time during the study visit;\n19. According to the researchers' judgment, the subjects have any other factors that are not suitable for participating in the clinical trial.",true,{"count":96,"type":20},620,[23,24],"This clinical trial adopts a seamless design of phase I\u002FII, conducted in two stages: phase I and phase II. Phase I is the age\u002Fdose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.",[28],"2026-04-29",{"date":102,"type":54},"2026-05-05",{"date":104,"type":54},"2025-05-08",{"date":106,"type":20},"2026-09",{"name":108,"class":61},"Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100489079","phase-2-a-phase-2-trial-comparing-antiviral-treatments-in-early-symptomatic-influenza-100489079","NCT05648448","A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza","ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)","AD ASTRA","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study\n* Adults, male or female, aged 18 to 60 years at time of consent.\n* Early symptomatic Influenza (A or B); at least one reported symptom of influenza (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)\n* Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza viruses within the last 24hrs with a Ct value of \\\u003C30\n* Able to walk unaided and unimpeded in activities of daily living (ADLs)\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity\n* Presence of any chronic illness\u002Fcondition requiring long term treatment or other significant comorbidity\n* BMI ≥35 Kg\u002Fm2\n* Clinically relevant laboratory abnormalities discovered at screening\n\n  * Haemoglobin \\\u003C10g\u002FdL\n  * Platelet count \\\u003C100,000\u002FuL\n  * ALT \\> 2x ULN\n  * Total bilirubin \\>1.5 x ULN\n  * eGFR \\\u003C70mls\u002Fmin\u002F1.73m2\n* For females: pregnancy, actively trying to become pregnant or lactation (healthy women on OCP are eligible to join)\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics\n* Currently participating in another interventional influenza or COVID-19 therapeutic trial\n* Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations (imaging not required)\n* Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)\n* Received live attenuated influenza virus vaccine within 3 weeks prior to study entry","60 Years",{"count":119,"type":20},3000,[24],"This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other.\n\nAD ASTRA study is supported by the Wellcome Trust Grant ref: 223195\u002FZ\u002F21\u002FZ through the COVID-19 Therapeutics Accelerator",[123,28],"Influenza",[123,125,126],"Phase 2","Antiviral Pharmacodynamics","2026-04-09",{"date":129,"type":54},"2026-04-14",{"date":131,"type":54},"2023-02-22",{"date":133,"type":20},"2027-01-01",{"name":135,"class":85},"University of Oxford",4,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":4,"enrollmentInfo":144,"targetDuration":146,"studyType":71,"phases":4,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":86},"100623211","effectiveness-of-xuanfei-jiangzhuo-decoction-for-influenza-induced-aecopd-100623211","NCT07393685","Effectiveness of Xuanfei Jiangzhuo Decoction for Influenza-Induced AECOPD","Effect of Xuanfei Jiangzhuo Decoction on Clinical Remission in Influenza-Induced AECOPD: Study Protocol for a Prospective, Real-World Cohort Study","Inclusion Criteria:\n\n* Diagnosed with Influenza-induced AECOPD according to the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (GOLD 2025) and the Expert Consensus on the Diagnosis and Treatment of AECOPD in China (Updated 2023), confirmed by spirometry and viral testing (antigen or PCR), and excluding pneumonia and heart failure via chest CT and NT-proBNP.\n* Aged 60 years or older.\n* Voluntarily participate and provide written informed consent..\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the study medications.\n* Presence of severe bacterial co-infection at enrollment requiring systemic antibiotic therapy.\n* Severe dysfunction of major organs that may interfere with efficacy or safety assessment (e.g., severe cardiac insufficiency, hepatic impairment, or renal failure).\n* Participation in other interventional clinical trials within the past 3 months.\n* Inability to be contacted for follow-up (e.g., lack of permanent address or valid contact information).\n* Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation (e.g., severe cognitive impairment or psychiatric disorders).",{"count":145,"type":20},300,"28 Days","The goal of this observational study is to learn if a traditional Chinese herbal medicine (Xuanfei Jiangzhuo Decoction) works to help older adults recover from a COPD flare-up caused by the flu (influenza virus). The main questions it aims to answer are:\n\nDoes the herbal medicine help participants feel better and recover faster? Does it lower the chance of getting a second infection from bacteria? Is the herbal medicine safe to use? Researchers will compare participants who choose to take the herbal medicine along with their standard flu treatment (Oseltamivir or Baloxavir) to participants who only take the standard flu treatment (Oseltamivir or Baloxavir).\n\nParticipants will:\n\nTake the herbal medicine (a liquid drink) twice a day for 5 days, or just take their standard flu medicine for 5 days.\n\nVisit the clinic 4 times over 28 days for checkups and tests. Provide blood and stool samples to help researchers understand how the medicine affects the body and gut health.\n\nAnswer simple questions about their cough, breathing, and energy levels.",[149,28,150],"Acute Exacerbation of Chronic Obstructive Pulmonary Disease","Virus Diseases",[152,153,154],"COPD Exacerbation","Real-World Study","Traditional Chinese Medicine","NOT_YET_RECRUITING","2026-03-09",{"date":158,"type":54},"2026-03-12",{"date":160,"type":20},"2026-08-01",{"date":162,"type":20},"2028-05-31",{"name":164,"class":85},"Tianjin Medical University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":94,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":86},"100447621","phase-4-characterization-of-humoral-and-cellular-immune-responses-elicited-by-influenza-vaccination-in-healthy-adults-100447621","NCT05108818","Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for all study visits\n3. Aged 18 years and older\n4. In good health based on self-reported medical conditions via an online survey\n\nExclusion Criteria:\n\n1. Known allergic reactions to components of the study vaccine\n2. Known latex allergy\n3. History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines\n4. History of GBS within 6 weeks of receipt of a previous influenza vaccine\n5. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months\n6. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study\n7. Active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy (\"active\" is defined as having received treatment within the past 5 years)\n8. Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids\n9. Administration of an influenza vaccine within 2 months prior to enrollment\n10. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses\n11. Participation in a study that involves an experimental agent or having received an experimental agent (other than a COVID-19 vaccine) within 1 month prior to enrollment or expecting to receive another experimental agent during the study period\n12. Intends to donate blood during the study period\n13. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol\n14. Pregnancy\n15. Known human immunodeficiency virus, hepatitis B, or hepatitis C infection\n16. Any condition that the principal investigator believes may interfere with successful completion of the study",{"count":172,"type":20},700,[174],"PHASE4","Cellular and humoral immune responses before and after seasonal influenza vaccination will be assessed. Each year, up to 100 participants will be enrolled. To study age-specific differences in immune responses, participants with various years of birth will be enrolled. The investigators hypothesize that humans with different birth years will mount antibody and cellular responses of different specificities following seasonal influenza vaccination.",[28],"2026-02-04",{"date":179,"type":54},"2026-02-09",{"date":181,"type":54},"2021-10-07",{"date":183,"type":20},"2028-03-31",{"name":84,"class":85},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100390606","phase-1-evaluating-avm0703-for-treatment-of-covid-19-or-influenza-mediated-ards-100390606","NCT04366115","Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS","A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome","AVM0703","Inclusion Criteria\n\nPatients who meet all of the following criteria will be eligible to participate in the study:\n\n1. Age ≥18 years;\n2. Must have laboratory confirmed COVID-19;\n3. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or B), as follows:\n\n   a. COVID-19 patients with ARDS (Berlin Criteria) as demonstrated by:\n\n   i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules;\n\n   ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and\n\n   iii. Impaired oxygenation defined as Moderate (partial pressure of oxygen \\[PaO2\\]:fraction of inspired oxygen \\[FiO2\\] ratio 100 mm Hg to \\\u003C200 mm Hg with positive end-expiratory airway pressure \\[PEEP\\] \\>5 cm H2O) or Severe (PaO2:FiO2 ratio \\\u003C100 mm Hg with PEEP\\>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;\n\n   b. Influenza (A or B) patients with ARDS (Berlin Criteria) as demonstrated by:\n\n   i. Chest radiograph or CT scan showing bilateral opacities not fully explained by effusions, lobar\u002Flung collapse, or nodules;\n\n   ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and\n\n   iii. Impaired oxygenation defined as Severe (PaO2:FiO2 ratio\\\u003C100 mm Hg with PEEP \\>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour period;\n4. Requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) despite standard of care rescue measures (eg, prone positioning, and\u002For PEEP ladder, and\u002For inhaled pulmonary vasodilators, and\u002For recruitment maneuvers and\u002For neuromuscular blockade);\n5. Females of childbearing potential must have a negative serum pregnancy test at screening;\n6. Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent through 1 month after study drug infusion; and\n7. Capable of providing informed consent, or if not capable, a legally authorized representative is capable of providing informed consent\n\nExclusion Criteria\n\nPatients who meet any of the following criteria will be excluded from participation in the study:\n\n1. Moribund patient who, in the opinion of the Investigator, is not expected to survive at least 24 hours;\n2. Known hypersensitivity or allergy to the study drug or any of its excipients;\n3. D-dimer level \\>3 times above normal range;\n4. Known gastric or duodenal ulcer;\n5. Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;\n6. Active and untreated bacterial, fungal, parasitic, or viral infection other than COVID-19 or Influenza (A or B). Patients with a history of a positive hepatitis B surface antigen and\u002For hepatitis B core antibody must have a negative hepatitis B polymerase chain reaction (PCR) assay result. Patients with history of a positive hepatitis C virus antibody test must have a negative hepatitis C PCR assay result;\n7. Positive testing for tuberculosis during screening;\n8. Known to have received a live vaccine within the previous 1 month;\n9. Immunocompromised patients, defined as those who have received a bone marrow or solid organ transplant on immunosuppressive therapy; or history of human immunodeficiency virus (HIV) infection who have not been taking anti retroviral therapy for at least 6 months before enrollment and\u002For with most recent CD4 count \\\u003C200 cells\u002FmL and\u002For most recent detectable viral load within the previous 6 months;\n10. Moderate to End-stage liver disease (Childs-Pugh Score \\>10);\n11. Dialysis-dependent due to underlying chronic renal disease. Note: patients who require dialysis for treatment of renal failure due to complications of COVID-19 or Influenza (A or B) infection are not excluded from enrollment;\n12. Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start of AVM0703 administration, including: angina requiring therapy, symptomatic peripheral vascular disease, New York Heart Association Class III or IV congestive heart failure, left ventricular ejection fraction \\\u003C30%, left ventricular fractional shortening \\\u003C20%, or uncontrolled Grade 3 hypertension (diastolic blood pressure \\[DBP\\] \\>100 mm Hg or systolic blood pressure \\[SBP\\] \\>150 mm Hg) despite antihypertensive therapy.\n\n    Note: patients with heart failure requiring medical support due solely to complications of COVID-19 infection are not excluded from enrollment;\n13. Significant screening 12-lead ECG abnormalities, including unstable cardiac arrhythmia requiring medication, atrial fibrillation\u002Fflutter, left bundle-branch block, second degree atrioventricular (AV) block type 2, third-degree AV block, Grade 2 bradycardia, or heart rate corrected QT interval using Fridericia's formula average of triplicate ECGs \\>450 ms;\n14. Manic-depressive disorder, schizophrenia, or a history of severe depression or substance abuse;\n15. Pregnant or breastfeeding;\n16. Concurrent enrollment in any other clinical study involving administration of a novel (ie, unapproved or not considered standard of care) investigational pharmacological agent(s). Concurrent enrollment in observational and device studies and studies involving administration of pharmacological agent(s) approved for other indications or considered emerging standard of care for treatment of COVID-19 (eg, hydroxychloroquine, remdesivir, low-dose dexamethasone), will be allowed if approved by the Sponsor;\n17. Treatment with standard of care or off-label treatments for COVID-19 (eg, remdesivir), not administered as part of a formal clinical study, where the first dose was initiated within 72 hours of study drug start; and\n18. Inability to obtain informed consent from the patient or legally authorized representative.",{"count":194,"type":20},16,[23],"This is a randomized, double-blinded, placebo-controlled study of AVM0703 administered as a single intravenous (IV) infusion to patients with moderate or severe immediately life-threatening Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 or influenza (A or B). The study is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose of AVM0703 in these ARDS patients.",[198,199,28],"ARDS","Covid19",[198,201,123],"COVID19","2025-09-29",{"date":204,"type":54},"2025-10-02",{"date":206,"type":20},"2026-12-01",{"date":208,"type":20},"2032-03-01",{"name":210,"class":61},"AVM Biotechnology Inc",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":94,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":86},"100543389","phase-1-covid-19-and-influenza-oral-vaccine-study-100543389","NCT06355232","Covid-19 and Influenza Oral Vaccine Study","A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Males or females 18 years of age or older\n* Understand and are likely to comply with planned study procedures and be available for all study visits.\n* Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6 months.\n\nExclusion Criteria:\n\n* Allergy to COVID-19 or seasonal influenza vaccine or one of its components e.g. polysorbate 80.\n* Have received a COVID-19 or influenza vaccine or an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent or a COVID-19 or influenza vaccine during the trial reporting period.\n* Any serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.",{"count":219,"type":20},100,[23],"The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral\u002F sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.",[223,28],"covid19 Infection",[225,226,227,228,229,230,231,232],"covid-19","influenza","pandemic","mucosal","spikogen","advax","adjuvant","vaccine","2025-09-16",{"date":235,"type":54},"2025-09-17",{"date":237,"type":54},"2024-05-01",{"date":239,"type":20},"2026-12-31",{"name":241,"class":61},"Vaxine Pty Ltd",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100400452","phase-2-an-intravenous-iv-zanamivir-pharmacokinetics-pk-study-in-hospitalized-neonates-and-infants-with-influenza-infection-100400452","NCT04494412","An Intravenous (IV) Zanamivir Pharmacokinetics (PK) Study in Hospitalized Neonates and Infants With Influenza Infection","An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection","Inclusion Criteria:\n\n* Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. Preterm neonates and infants will be eligible for inclusion but must have reached PMA of at least 28 weeks.\n* Participants who are hospitalized with influenza infection, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative Reverse transcriptase-polymerase chain reaction (RT-PCR) test and who must have a potential for improvement Participants with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR.\n* Participants with a high risk of altered oral drug absorption, represented by multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the treating physician). (applicable only for Netherlands)\n* Body weight \\>=1 kilograms (kg).\n* No gender restriction.\n* LAR of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, Independent Ethics Committees \\[IECs\\] or local laws).\n\nExclusion criteria:\n\n* Participants who are known or suspected to be hypersensitive to any component of the study medication.\n* Participants with a disease process which is likely to be irreversible.\n* Liver function:\n\n  * Participants who meet the following criteria at Baseline:\n\n    1. Alanine transaminase (ALT) \\>=3 times upper limit of normal (ULN) with bilirubin \\>=2 times ULN\n    2. or isolated bilirubin \\>=2 times ULN and \\>50 percent (%) direct bilirubin\n    3. or ALT \\>=5 times ULN Inclusion of participants with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor.\n  * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of participants with neonatal hyperbilirubinemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor (Not-applicable for Great Britain).\n* Participants who require concurrent therapy with another anti influenza drug.\n* Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.\n* Child in care (CiC), as defined below:\n\n  * A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.\n  * The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.\n* Participants undergoing treatment by Extracorporeal membrane oxygenation (ECMO) or hemofiltration.\n* Participants who are positive for severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) as determined by a diagnostic test, at screening","6 Months",{"count":251,"type":20},12,[24],"Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, there are no licensed influenza vaccines for children aged less than six months old. As a requirement of the Pediatric Investigation Plan European Union (EU), GlaxoSmithKline (GSK) will be conducting this open-label, multi-center, single arm, post-marketing authorization study to evaluate the PK and collect safety and tolerability information of IV zanamivir in hospitalized neonates and infants under 6 months of age with confirmed complicated influenza infection. The total duration of study participation for each participant will be up to 24 days with a study treatment period up to 10 days and 14 days of post-treatment follow up. However, for a given participant, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms, participant characteristics or virological tests as assessed by the investigator warrant further treatment. DECTOVA is a trademark of GlaxoSmithKline group of companies.",[28,255],"Arthralgia",[257,258,259,260],"Human influenza","Zanamivir","Pediatric","Hospitalized neonates and infants","2025-03-14",{"date":263,"type":54},"2025-03-17",{"date":265,"type":54},"2022-11-21",{"date":267,"type":20},"2026-04-30",{"name":269,"class":61},"GlaxoSmithKline",9,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":94,"sex":16,"minAge":278,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":62},"100577642","phase-3-phase-iii-clinical-trial-of-quadrivalent-influenza-virus-split-vaccine-100577642","NCT06800950","Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine","A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above","Inclusion Criteria:\n\n* Age Requirement: volunteers aged 3 years and above at the time of enrollment.\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Requirements for contraception: agree to take contraception actions in 6 months.\n* Temperature Requirement: Axillary body temperature is less than 37.3°C.\n* Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria will be not eligible for enrollment.\n\n* Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).\n* Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.\n* Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.\n* Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and\u002For urticaria, etc.\n* History of taking administration of a non-SARS-CoV-2 inactivated vaccine or subunit vaccine within 7 days before enrollment, or any live attenuated vaccine or SARS-CoV-2 vaccine within 14 days before enrollment, or subjects have scheduled to receive another vaccine within 1 month after receipt of the investigational vaccine\n* Subjects with convulsion, epilepsy, encephalopathy (such as moderate to severe hypoxic-ischemic encephalopathy, intracranial hemorrhage, cerebral palsy, intracranial tumor, cerebral infarction, stroke, intracranial infection, etc.), psychiatric history or family history\n* Have been diagnosed with a serious medical condition or congenital malformation that may interfere with the conduct or completion of the study (including but not limited to suffering from respiratory diseases such as asthma or during episodes of chronic bronchitis, Down syndrome, thalassemia, heart disease, severe cardiac arrhythmias, kidney disease, diabetes (diabetics with poor glycemic control or severe complications), autoimmune diseases, genetic allergies, Guillain-Barre syndrome, Crohn disease, malignancies, severe infectious\u002Fallergic skin diseases, etc.)\n* Adults aged 18 years or older with medically uncontrolled abnormal blood pressure (systolic blood pressure ≥140mmHg and\u002For diastolic blood pressure ≥90mmHg or systolic blood pressure ≤ 90mmHg and\u002For diastolic blood pressure ≤ 60 mmHg)\n* Subjects with acute illness or in the acute phase of a chronic illness within 3 days before vaccination\n* Subjects with fever (axillary temperature ≥37.3 ° C) within 3 days before vaccination or use of antipyretic, analgesic, or antiallergic medications\n* Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders\n* Have received a blood transfusion or use of blood products within 3 months before enrollment, or planned to do so within 1 month after full immunization\n* History of surgical removal of the spleen or other vital organs for any reason\n* Use of any investigational or unregistered product (drug, vaccine, biological product, or device) other than a study vaccine within 3 months before enrollment or planned for use during the study\n* Have treatment with immunosuppressive agents within 6 months before enrollment, such as long-term systemic glucocorticoid therapy (e.g., prednisone or a similar drug for more than 2 consecutive weeks within 6 months), but topical use (e.g., ointments, eye drops, inhalers, or nasal sprays) was allowed. Topical use should not exceed the recommended dose on the label or have any signs of systemic exposure\n* Have been diagnosed with an infectious disease that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, etc\n* Being lactating, pregnant (including a positive urine pregnancy test), or planning to become pregnant within 6 months of vaccination\n* Subjects plan to move out of the local area before the end of the study or leave the local area for an extended period during the scheduled study visit\n* Subjects with abnormal vital signs with clinical significance\n* Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.","3 Years",{"count":280,"type":20},4400,[282],"PHASE3","This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events\u002Fadverse reactions within 30 minutes\u002F7 days\u002F30 days after immunization, as well as the incidence of serious adverse events\u002Fadverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.",[28,285,286,287,288],"Influenza, Human Prevention","Influenza a","Influenza B","Influenza Viral Infections","2025-01-24",{"date":291,"type":54},"2025-01-30",{"date":293,"type":20},"2025-02-08",{"date":295,"type":20},"2025-10-15",{"name":297,"class":85},"Institute of Medical Biology, Chinese Academy of Medical Sciences",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":94,"sex":16,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":86},"100560120","phase-3-study-of-gp681-tablets-compared-with-placebo-in-patients-with-influenza-at-high-risk-of-influenza-complications-100560120","NCT06573008","Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications","A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Safety and Efficacy of GP681 Tablets in Patients With Influenza at High Risk of Influenza Complications","Inclusion Criteria:\n\n1. Male or female patients aged ≥12 years at the time of signing the informed consent form.\n2. Patients with a diagnosis of influenza confirmed by all of the following:\n\n   * Positive throat or nose swab by rapid influenza antigen test (RAT) (where rapid influenza virus nucleic acid test or other rapid molecular diagnostic methods are also acceptable);\n\n     * Fever (axillary temperature ≥37.3℃) in the predose examinations or \\> 4 hours after dosing of antipyretics if they were taken;\n\n       * At least one of the following systemic symptoms and respiratory symptoms respectively associated with influenza are present with a severity of moderate or greater:\n\n   Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue; Respiratory system symptoms: cough, sore throat, nasal congestion.\n3. The time interval between the onset of symptoms and random enrollment is 48 hours or less. The onset of symptoms is defined as either:\n\n   1. Time of the first increase in body temperature (axillary temperature ≥37.3℃)\n   2. Time when the patient experiences at least 1 new general or respiratory symptom related to influenza\n4. Referring to the standards of the Centers for Disease Control and Prevention (CDC) in the United States and the definition of high-risk populations for influenza complications in the \"Expert Consensus on Diagnosis and Treatment of Influenza in Adults in the Emergency Department (2022 Edition)\", that is, if at least one of the following criteria is met, the patient will be considered at high risk of influenza complications:\n\n   1. Asthma or chronic lung diseases \\[such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, chronic bronchitis, bronchiectasis, emphysema, chronic interstitial pneumonia, etc.\\];\n   2. Endocrine disorders (including diabetes);\n   3. Residents of long-term care institutions (such as nursing homes);\n   4. Immune system impairment (including patients receiving chronic systemic corticosteroid treatment of ≤20mg\u002Fd prednisone or an equivalent dose);\n   5. Neurological and neurodevelopmental disorders (including brain, spinal cord, peripheral nerve and muscle diseases, such as cerebral palsy, epilepsy (episodic disorders), stroke, muscular dystrophy or spinal cord injury);\n   6. Heart diseases (such as congenital heart disease, congestive heart failure, or coronary artery disease), but not including hypertension without any other cardiac-related symptoms;\n   7. Patients aged ≥65 years;\n   8. Blood system diseases (such as sickle cell disease);\n   9. Metabolic system diseases (such as hereditary metabolic diseases and mitochondrial diseases);\n   10. Liver diseases (such as chronic hepatitis B, chronic hepatitis C, non-alcoholic steatohepatitis);\n   11. Kidney diseases (estimated glomerular filtration rate eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula);\n   12. Obese patients (BMI ≥ 30 kg\u002Fm2);\n   13. Female patients within 2 weeks postpartum and not breastfeeding.\n5. Subjects of child-bearing potential who agree to use a highly effective method of contraception for 1 month after drug withdrawal.\n6. Subjects and\u002For their guardian who are willing to provide written informed consent and consent to participate in the study, able to understand the study and comply with all study procedures, including patient health diary records.\n\nExclusion Criteria:\n\n1. History of allergic reactions attributed to GP681,Acetaminophen, bromohexine hydrochloride or any of the ingredients of its formulation.\n2. Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to chronic diarrhea, inflammatory bowel disease, tuberculosis of the intestines, gastrinoma, short bowel syndrome, postoperative gastrectomy, etc.);\n3. Screening patients who, in the opinion of the investigator, require hospitalization due to severe influenza virus infection;.\n4. Screening patients who, at the time of screening, are clinically diagnosed with bacterial or other viral infections requiring systemic antibacterial or antiviral treatment;\n5. Cancer patients who are currently receiving or have received chemotherapy or radiation therapy within the past year (excluding non-melanoma skin cancer and thyroid cancer)\n6. Known HIV-infected patients;\n7. Organ or bone marrow transplant recipients;\n8. Patients who are currently receiving \\>20mg\u002Fd of prednisone or equivalent chronic systemic corticosteroid therapy;\n9. Patients who have used anti-influenza virus drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, palivizumab, favipiravir, abidol, marabolexavir, amantadine or rimantadine or other anti-influenza virus drugs approved by NMPA) within the past 2 weeks or who have received influenza vaccination within the past 6 months;\n10. Exclusion of participants who have received clinical research or screening within the past 30 days for any indication with a trial drug or device, or who have received clinical research for a monoclonal antibody drug for viral diseases within the past year;\n11. Known to have had a previous history of severe liver function impairment such as cirrhosis with ascites, hepatic encephalopathy, or a history of upper gastrointestinal bleeding;\n12. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \\\u003C30mL\u002Fmin\u002F1.73m2 at the time of screening;\n13. Individuals with a history of alcohol abuse or substance abuse (more than 14 units of alcohol per week, 1 unit of alcohol = 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine with an alcohol content of 12%);\n14. Adult reproductive-age females who are pregnant or breastfeeding or who have a positive pregnancy test. Women who are infertile (i.e., women who have had a hysterectomy, bilateral oophorectomy, or tubal ligation for medical reasons or who are postmenopausal - defined as age \\> 50 years and menopause has occurred for at least 2 years) do not need a pregnancy test;\n15. Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.","12 Years",{"count":307,"type":20},328,[282],"This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 and older With Influenza at High Risk of Influenza Complications.",[28],"2024-12-01",{"date":313,"type":54},"2024-12-04",{"date":315,"type":54},"2024-11-11",{"date":317,"type":20},"2025-12-30",{"name":319,"class":61},"Jiangxi Qingfeng Pharmaceutical Co. Ltd."]