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

NCT06667063 | Recruiting

• 1 other identifier: AMMS85-2401
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COVID-19; Influenza

Keywords

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

Outcome Measures

Primary Outcomes (6)

• The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform.

  Measuring method: Single-cell RNA sequencing. Metric/method of measurement: cell frequency

  From the enrollment to the end of the visit on the 28th ± 3rd day

• The Ct value of SARS-CoV-2 N gene, Influenza A HA gene and Influenza B PA gene in mucosal sample as assessed by Real-Time RT-PCR

  Measuring method: Real-Time RT-PCR Metric/method of measurement: Ct value

  From the enrollment to the end of the visit on the 28th ± 3rd day

• The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA.

  Measuring method: ELISA Metric/method of measurement: antibody titer

  From the enrollment to the end of the visit on the 28th ± 3rd day

• The level of IL-1β, IL-6, IFN-gamma, MCP-1, CXCL9, CXCL10, MCP-1 and TNF-alpha in serum sample assessed by Luminex.

  Measuring method: Luminex Metric/method of measurement: concentration

  From the enrollment to the end of the visit on the 28th ± 3rd day

• The transcriptome profiles of peripheral blood mononuclear cell assessed by RNA-sequencing Measuring method: RNA-sequencing

  Metric/method of measurement: gene count

  From the enrollment to the end of the visit on the 28th ± 3rd day

• The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in blood sample as assessed by the flow cytometer

  Measuring method: flow cytometer Metric/method of measurement: cell frequency

  From the enrollment to the end of the visit on the 28th ± 3rd day

Study Arms (3)

Cohort 1:COVID-19 infected persons

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;

Other: Nasal swab/Nasopharyngeal swab/Blood sample collection

Cohort 2:Influenza virus infected persons

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;

Other: Nasal swab/Nasopharyngeal swab/Blood draw

Cohort 3: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. COVID-19 and influenza virus antigen-negative, no febrile symptoms, and no symptoms of viral or bacterial respiratory infections.

Other: Nasal swab/Nasopharyngeal swab/Blood draw

Interventions

Nasal swab/Nasopharyngeal swab/Blood sample collection OTHER

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

Cohort 1:COVID-19 infected persons

Nasal swab/Nasopharyngeal swab/Blood draw OTHER

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

Cohort 2:Influenza virus infected persons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is planned to include 50 patients infected with novel coronavirus, 50 patients infected with influenza virus and 30 healthy volunteers.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• has received other vaccines or investigational drugs within the past 1 month;
• is receiving anti-tuberculosis treatment;
• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead
• Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China: collaborator

Study Sites (2)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (3)

• Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25.

  PMID: 34174187 BACKGROUND

• Su Y, Chen D, Yuan D, Lausted C, Choi J, Dai CL, Voillet V, Duvvuri VR, Scherler K, Troisch P, Baloni P, Qin G, Smith B, Kornilov SA, Rostomily C, Xu A, Li J, Dong S, Rothchild A, Zhou J, Murray K, Edmark R, Hong S, Heath JE, Earls J, Zhang R, Xie J, Li S, Roper R, Jones L, Zhou Y, Rowen L, Liu R, Mackay S, O'Mahony DS, Dale CR, Wallick JA, Algren HA, Zager MA; ISB-Swedish COVID19 Biobanking Unit; Wei W, Price ND, Huang S, Subramanian N, Wang K, Magis AT, Hadlock JJ, Hood L, Aderem A, Bluestone JA, Lanier LL, Greenberg PD, Gottardo R, Davis MM, Goldman JD, Heath JR. Multi-Omics Resolves a Sharp Disease-State Shift between Mild and Moderate COVID-19. Cell. 2020 Dec 10;183(6):1479-1495.e20. doi: 10.1016/j.cell.2020.10.037. Epub 2020 Oct 28.

  PMID: 33171100 BACKGROUND

• Clementi N, Ghosh S, De Santis M, Castelli M, Criscuolo E, Zanoni I, Clementi M, Mancini N. Viral Respiratory Pathogens and Lung Injury. Clin Microbiol Rev. 2021 Mar 31;34(3):e00103-20. doi: 10.1128/CMR.00103-20. Print 2021 Jun 16.

  PMID: 33789928 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Nasal mucosa/Nasopharyngeal mucosa/Blood

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Central Study Contacts

Jianying Huang

CONTACT

02167811702; znyylcsy@126.com

Jian Xia

CONTACT

02167812521; jianxia@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 31, 2024
• Study Start: September 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

CN (2)