Clinical Study on the Immune Response Characteristics of Novel Coronavirus and Influenza Virus Infection

Sponsor
Zhongnan Hospital
Study ID
NCT06667063
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nasal swab/Nasopharyngeal swab/Blood sample collection — OTHER
    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
    Visit 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
    Visit 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

Study Details

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.

Key Dates

First listed
Oct 31, 2024
Start date
Sep 19, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Cohort 1:COVID-19 infected persons
    Inclusion Criteria: 1. volunteers aged 18 years and above at the time of screening; 2. informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form; 3. an interval of ≥3 months from the last COVID-19 or influenza vaccination; 4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs; 5. COVID-19 antigen-positive and within 48 hours of onset of symptoms of infection;
  • Arm: Cohort 2:Influenza virus infected persons
    Inclusion Criteria: 1. volunteers aged 18 years and above at the time of screening; 2. informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form; 3. an interval of ≥3 months from the last COVID-19 or influenza vaccination; 4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs; 5. influenza virus antigen-positive and within 48 hours of onset of symptoms of infection;
  • Arm: Cohort 3:Healthy Volunteers
    Inclusion Criteria: 1. volunteers aged 18 years and above at the time of screening; 2. informed consent obtained from volunteers and volunteers/witnesses able to sign the informed consent form; 3. an interval of ≥3 months from the last COVID-19 or influenza vaccination; 4. an interval of ≥ 3 months from the last respiratory viral infection such as COVID-19 or Influenza virus occurs; 5. COVID-19 and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.

Primary Outcome Measure

The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform. [ Time Frame: From the enrollment to the end of the visit on the 28th ± 3rd day ]

Central Contacts

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