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

Zhongnan Hospital

Status: Enrolling

Conditions: COVID-19; Influenza

Treatments: Other: Nasal swab/Nasopharyngeal swab/Blood sample collection; Other: Nasal swab/Nasopharyngeal swab/Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT06667063

AMMS85-2401

Details and patient eligibility

About

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.

Full description

The clinical trial enrolls 130 subjects aged 18 years and older with ≥3 months between their last COVID-19/influenza 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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; 5.1 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.

Exclusion criteria

1. 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;
2. Absence of spleen or functional absence of spleen;
3. 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;
4. Received blood products within the past 3 months;
5. has received other vaccines or investigational drugs within the past 1 month;
6. is receiving anti-tuberculosis treatment;
7. 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.

Trial design

130 participants in 3 patient groups

Cohort 1:COVID-19 infected persons

Description:

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;

Treatment:

Other: Nasal swab/Nasopharyngeal swab/Blood sample collection

Cohort 2:Influenza virus infected persons

Description:

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;

Treatment:

Other: Nasal swab/Nasopharyngeal swab/Blood draw

Other: Nasal swab/Nasopharyngeal swab/Blood draw

Cohort 3:Healthy Volunteers

Description:

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.

Treatment:

Other: Nasal swab/Nasopharyngeal swab/Blood draw

Other: Nasal swab/Nasopharyngeal swab/Blood draw