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

Primary Purpose

Corona Virus Infection

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ELISPOT
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Corona Virus Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient group

control group

Arm Description

- 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.

- 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Anti-SARS-CoV-2 IgG and IgM levels
Anti-SARS-CoV-2 IgG and IgM levels
SARS-CoV-2 viral load in nasopharyngeal swab
SARS-CoV-2 viral load in nasopharyngeal swab

Full Information

First Posted
December 29, 2020
Last Updated
January 12, 2021
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04707820
Brief Title
Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection
Acronym
ImmuCoV
Official Title
Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
June 10, 2021 (Anticipated)
Study Completion Date
June 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Experimental
Arm Description
- 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
- 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
Intervention Type
Diagnostic Test
Intervention Name(s)
ELISPOT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to the S protein
Description
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
Time Frame
for 56 days
Secondary Outcome Measure Information:
Title
Numbers of T lymphocytes producing IFN in response to other CoV-2-SARS viral
Description
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
Time Frame
for 56 days
Title
Anti-SARS-CoV-2 IgG and IgM levels
Description
Anti-SARS-CoV-2 IgG and IgM levels
Time Frame
for 56 days
Title
SARS-CoV-2 viral load in nasopharyngeal swab
Description
SARS-CoV-2 viral load in nasopharyngeal swab
Time Frame
for 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nell Marty, PhD
Phone
0033 02 32 88 82 65
Email
Nell.Marty@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
David Mallet
Phone
0033 02 32 88 82 65
Email
secretariat.drc@chu-rouen.fr
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde LEMOINE, Doctor

12. IPD Sharing Statement

Learn more about this trial

Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

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