Official Title
Clinical Study on the Immune Response Characteristics of Novel Coronavirus and Influenza Virus Infection
Brief Summary

This is an open-label, prospective observational study in people 18 years of age andolder designed to track changes in the dynamics of the respiratory and peripheral bloodimmune response in people infected with influenza virus and new coronaviruses, and toresolve 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.

Recruiting
COVID-19
Influenza

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China

Contacts

Jianying Huang
02167811702
znyylcsy@126.com

Jian Xia
02167812521
jianxia@whu.edu.cn

Not Provided

Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
NCT Number
Keywords
Covid-19
Influenza
Immune response characteristics
Clinical Study
MeSH Terms
COVID-19
Influenza, Human
Virus Diseases