Observing immune responses in COVID-19 and influenza infections

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

This study is trying to see how the immune system reacts in people with COVID-19 and influenza by looking at samples from their blood and mucous during infection and recovery.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06667063 on ClinicalTrials.gov

What this trial studies

This observational study aims to track the immune response dynamics in individuals infected with COVID-19 and influenza. It will enroll 130 participants aged 18 and older, who will provide mucosal and blood samples during different stages of infection and recovery. The study will analyze cytokine levels, immune cell types, gene transcription, and specific antibody levels to understand the natural immune response to these viruses.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have not been vaccinated or infected with respiratory viruses in the last three months.

Not a fit: Patients with serious underlying health conditions or recent respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of immune responses to COVID-19 and influenza, potentially leading to improved treatments and vaccines.

How similar studies have performed: Other studies have explored immune responses to respiratory viruses, but this specific approach to comparing COVID-19 and influenza responses is relatively novel.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Jianying Huang

Conditions COVID-19; Influenza; Immune response characteristics; Clinical study