Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection (ImmuCoV)

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.

Study Overview

• Status: Unknown
• Conditions: Corona Virus Infection
• Intervention / Treatment: Diagnostic test: ELISPOT

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nell Marty, PhD; Phone Number: 0033 02 32 88 82 65; Email: Nell.Marty@chu-rouen.fr
• Study Contact Backup: Name: David Mallet; Phone Number: 0033 02 32 88 82 65; Email: secretariat.drc@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • ROUEN university hospital
    • Contact: Mathilde LEMOINE, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient group; - 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.	Diagnostic test: ELISPOT; The evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to Spike glycoprotein (Spike glycoprotein) will be assessed by enumeration in ELISPOT method at 4 measurement times: D0 (confirmation of infection by PCR), D+7, D+14 or at hospital departure (D+Departure) and D+56±14 days. The ELISPOT method consists in stimulating peripheral blood mononuclear cells (isolated by density gradient and containing a known CD3+ T lymphocyte count) over a short period of time (16 to 20 hours) with a pool of 15 amino acid peptides (overlapping on 11 amino acids) representative of the S protein.
No Intervention: control group; - 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein	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	for 56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral	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	for 56 days
Anti-SARS-CoV-2 IgG and IgM levels	Anti-SARS-CoV-2 IgG and IgM levels	for 56 days
SARS-CoV-2 viral load in nasopharyngeal swab	SARS-CoV-2 viral load in nasopharyngeal swab	for 56 days

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): June 10, 2021
• Study Completion (Anticipated): June 10, 2021

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases
• Other Study ID Numbers: 2020/0100/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No