Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

Corona Virus Infection Clinical Trial

— ImmuCoV  

Official title:

Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707820
• Other study ID #: 2020/0100/HP
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Rouen
• Contact: Nell Marty, PhD
• Phone: 0033 02 32 88 82 65
• Email: Nell.Marty[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Anti-SARS-CoV-2 IgG and IgM levels	Anti-SARS-CoV-2 IgG and IgM levels	for 56 days
Secondary	SARS-CoV-2 viral load in nasopharyngeal swab	SARS-CoV-2 viral load in nasopharyngeal swab	for 56 days