NCT06667063

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• COVID-19
• Influenza

Interventions

Type	Name	Description
OTHER	Nasal swab/Nasopharyngeal swab/Blood 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
OTHER	Nasal swab/Nasopharyngeal swab/Blood draw	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
OTHER	Nasal swab/Nasopharyngeal swab/Blood draw	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

Timeline

• Start date: 2024-09-19
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2024-10-31
• Last updated: 2024-10-31

Locations

2 sites across 1 country: China