Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

Not Applicable

• Conditions: Corona Virus Infection
• Interventions: Diagnostic Test: ELISPOT

• Registration Number: NCT04707820
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.

Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.

To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.

In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Status Verified: 2020-12
• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic form requiring oxygen therapy < 4 L/min.)
• Rouen University Hospital staff free of any symptomatology compatible with an SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since February 1, 2020
• Age ≥ 18 years old
• Adult patient who has read and understood the information letter and signed the consent form
• Affiliation to a social security scheme

Exclusion Criteria

• Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care units (acute respiratory distress and/or organ failure, whose pathogenesis may differ from the more frequently described forms with secondary aggravation (5)).
• Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form, managed by confinement)
• A person participating in a therapeutic trial that may interfere with the procedures being investigated, including lymphocyte response prior to D+56±14 days.
• Known Pregnancy
• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
• Staff at the Rouen University Hospital with SARS-CoV-2 infection confirmed by PCR and/or typical scan images during the epidemic period.
• Hospital staff who were exposed to the virus (working in a Covid unit)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient group	ELISPOT	- Patient with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images, requiring hospitalization in a COVID unit at Rouen University Hospital.

Primary Outcome Measures

Name	Time	Method
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein	for 56 days	The evolution of the number of interferon-gamma producing T lymphocytes (IFN) in response to protein S (Spike glycoprotein) will be assessed by enumeration in ELISPOT method

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 viral load in nasopharyngeal swab	for 56 days	SARS-CoV-2 viral load in nasopharyngeal swab
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral	for 56 days	Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral proteins (nucleoprotein, membrane proteins E (FEV1) and M (FEV1), proteins 3a, 9b, ORF10, non-structural proteins 6, 7a, 7b, 8, protein14) measured by ELISPOT
Anti-SARS-CoV-2 IgG and IgM levels	for 56 days	Anti-SARS-CoV-2 IgG and IgM levels

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France