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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZhongnan Hospital

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

Qualifiers

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 design

Treatments tested in this trial

  • Nasal swab/Nasopharyngeal swab/Blood sample collection
  • Nasal swab/Nasopharyngeal swab/Blood draw
  • Nasal swab/Nasopharyngeal swab/Blood draw

Treatment groups

130 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Zhongnan Hospital

Lead sponsor

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China

Collaborator