About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
volunteers aged 18 years and above at the time of screening;
informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form;
an interval of ≥3 months from the last COVID-19 or influenza vaccination;
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.
Disqualifiers
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;
Absence of spleen or functional absence of spleen;
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;
Received blood products within the past 3 months;
Trial population
This study is planned to include 50 patients infected with novel coronavirus, 50 patients infected with influenza virus and 30 healthy volunteers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Nasal swab/Nasopharyngeal swab/Blood sample collection
Other interventionCollect 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
Nasal swab/Nasopharyngeal swab/Blood draw
Other interventionVisit 1/2/3：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
Nasal swab/Nasopharyngeal swab/Blood draw
Other interventionVisit 1/2/3：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
Treatment groups
Trial outcomes
Primary outcomes
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/method of measurement: cell frequency
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/method of measurement: Ct value
The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA.
Measuring method: ELISA Metric/method of measurement: antibody titer
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/method of measurement: concentration
Sponsors and contacts
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Zhongnan Hospital
Lead sponsor
Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Collaborator