[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567351":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":49,"overallOfficials":28,"centralContacts":60,"locations":70,"responsibleParty":97,"collaborators":100,"id":103,"slug":28,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":28,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":28,"enrollmentInfo":111,"targetDuration":114,"studyType":115,"phases":28,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":73,"whyStopped":28,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Zhongnan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":28},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform.","Measuring method: Single-cell RNA sequencing. Metric\u002Fmethod of measurement: cell frequency","From the enrollment to the end of the visit on the 28th ± 3rd day",{"measure":14,"description":15,"timeFrame":12},"The Ct value of SARS-CoV-2 N gene, Influenza A HA gene and Influenza B PA gene in mucosal sample as assessed by Real-Time RT-PCR","Measuring method: Real-Time RT-PCR Metric\u002Fmethod of measurement: Ct value",{"measure":17,"description":18,"timeFrame":12},"The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA.","Measuring method: ELISA Metric\u002Fmethod of measurement: antibody titer",{"measure":20,"description":21,"timeFrame":12},"The level of IL-1β, IL-6, IFN-gamma, MCP-1, CXCL9, CXCL10, MCP-1 and TNF-alpha in serum sample assessed by Luminex.","Measuring method: Luminex Metric\u002Fmethod of measurement: concentration",{"measure":23,"description":24,"timeFrame":12},"The transcriptome profiles of peripheral blood mononuclear cell assessed by RNA-sequencing Measuring method: RNA-sequencing","Metric\u002Fmethod of measurement: gene count",{"measure":26,"description":27,"timeFrame":12},"The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in blood sample as assessed by the flow cytometer","Measuring method: flow cytometer Metric\u002Fmethod of measurement: cell frequency",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","The clinical trial enrolls 130 subjects aged 18 years and older with ≥3 months between their last COVID-19\u002Finfluenza vaccination or respiratory virus infection. Mucosal and peripheral blood samples will be collected from COVID-19-infected and influenza-infected patients during the preinfection, infection, and recovery periods, and cytokines, immune cell typing, immune cell transcription, and specific antibody levels will be examined in these patients. Levels of cytokines, immune cell typing, immune cell gene transcription, specific antibodies, etc.","This study is planned to include 50 patients infected with novel coronavirus, 50 patients infected with influenza virus and 30 healthy volunteers.",[35,40,45],{"label":36,"type":28,"description":37,"interventionNames":38},"Cohort 1:COVID-19 infected persons","Inclusion Criteria:\n\n1. volunteers aged 18 years and above at the time of screening;\n2. informed consent obtained from volunteers and volunteers\u002Fwitnesses able to sign the informed consent form;\n3. an interval of ≥3 months from the last COVID-19 or influenza vaccination;\n4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs;\n5. COVID-19 antigen-positive and within 48 hours of onset of symptoms of infection;",[39],"Other: Nasal swab\u002FNasopharyngeal swab\u002FBlood sample collection",{"label":41,"type":28,"description":42,"interventionNames":43},"Cohort 2:Influenza virus infected persons","Inclusion Criteria:\n\n1. volunteers aged 18 years and above at the time of screening;\n2. informed consent obtained from volunteers and volunteers\u002Fwitnesses able to sign the informed consent form;\n3. an interval of ≥3 months from the last COVID-19 or influenza vaccination;\n4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs;\n5. influenza virus antigen-positive and within 48 hours of onset of symptoms of infection;",[44],"Other: Nasal swab\u002FNasopharyngeal swab\u002FBlood draw",{"label":46,"type":28,"description":47,"interventionNames":48},"Cohort 3:Healthy Volunteers","Inclusion Criteria:\n\n1. volunteers aged 18 years and above at the time of screening;\n2. informed consent obtained from volunteers and volunteers\u002Fwitnesses able to sign the informed consent form;\n3. an interval of ≥3 months from the last COVID-19 or influenza vaccination;\n4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs;\n5. COVID-19 and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.",[44],[50,54,58],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":28},"Nasal swab\u002FNasopharyngeal swab\u002FBlood sample collection","Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing",[36],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":28},"Nasal swab\u002FNasopharyngeal swab\u002FBlood draw","Visit 1\u002F2\u002F3：Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing",[41],{"type":6,"name":55,"description":56,"armGroupLabels":59,"otherNames":28},[46],[61,66],{"name":62,"role":63,"phone":64,"phoneExt":28,"email":65},"Jianying Huang","CONTACT","02167811702","znyylcsy@126.com",{"name":67,"role":63,"phone":68,"phoneExt":28,"email":69},"Jian Xia","02167812521","jianxia@whu.edu.cn",[71,90],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Zhongnan Hospital of Wuhan University","RECRUITING","Wuhan","Hubei","430000","China","CN",{"type":80,"coordinates":81},"Point",[82,83],114.26667,30.58333,{"lat":83,"lon":82},[86,87],{"name":62,"role":63,"phone":64,"phoneExt":28,"email":65},{"name":88,"role":63,"phone":89,"phoneExt":28,"email":28},"Jianyuan Wu","02167812668",{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},{"type":80,"coordinates":92},[82,83],{"lat":83,"lon":82},[95,96],{"name":67,"role":63,"phone":68,"phoneExt":28,"email":69},{"name":88,"role":63,"phone":89,"phoneExt":28,"email":28},{"type":98,"investigatorFullName":62,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Chief Physician",[101],{"name":102,"class":6},"Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China","100567351",false,"NCT06667063","Clinical Study on the Immune Response Characteristics of Novel Coronavirus and Influenza Virus Infection","Inclusion Criteria:\n\n1. volunteers aged 18 years and above at the time of screening;\n2. informed consent obtained from volunteers and volunteers\u002Fwitnesses able to sign the informed consent form;\n3. an interval of ≥3 months from the last COVID-19 or influenza vaccination;\n4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs; 5.1 cohort 1：novel coronavirus virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.2 cohort 2：influenza virus antigen-positive and within 48 hours of onset of symptoms of infection; 5.3 cohort 3：novel coronavirus and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.\n\nExclusion Criteria:\n\n1. known or suspected concomitant more serious and medically unstable disease in the judgment of the investigator, including: respiratory disease, tuberculosis, acute infections or active chronic disease, hepatic or renal disease, cardiovascular disease (cardiorespiratory failure), hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), malignant tumors, infectious or allergic skin diseases, and the presence of HIV infection;\n2. Absence of spleen or functional absence of spleen;\n3. immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and superficial corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months;\n4. Received blood products within the past 3 months;\n5. has received other vaccines or investigational drugs within the past 1 month;\n6. is receiving anti-tuberculosis treatment;\n7. In the judgment of the investigator, due to a variety of medical, psychological, social, or other conditions that are contrary to the trial protocol or that affect the signing of informed consent by the volunteer.",true,"ALL","18 Years",{"count":112,"type":113},130,"ESTIMATED","28 Days","OBSERVATIONAL","This is an open-label, prospective observational study in people 18 years of age and older designed to track changes in the dynamics of the respiratory and peripheral blood immune response in people infected with influenza virus and new coronaviruses, and to resolve the characteristics of the virus-induced natural immune response.",[118,119],"COVID-19","Influenza",[118,119,121,122],"Immune response characteristics","Clinical study","2024-10-30",{"date":125,"type":126},"2024-10-31","ACTUAL",{"date":128,"type":126},"2024-09-19",{"date":130,"type":113},"2025-06-30",{"name":5,"class":6},2]