Evaluation and Longitudinal Follow-up of Biomarkers Predictive of Severe Forms of COVID-19 (COVIMMUNITY)

Current data in the literature demonstrate that the immune response to CoV-2-SARS is much more complex than initially assumed. In fact, beyond the humoral response, including the existence of neutralizing CAs, the adaptive lymphocyte T-type immune response also appears to play an important role in controlling the infection and reducing the severity of the disease. At this stage, the analysis of this T response is still rudimentary and underdeveloped, but it seems crucial to be able to analyze it effectively in COVID-19 patients, which could help predict the evolution of the infection. It is also currently difficult to know the evolution of this response over time and especially after the resolution of the infection.

To this end, we will analyze the T lymphocyte response (ELISPOT and QUANTIFERON) based on the secretion of IFN (Th1) and IL-4 (Th2) by CoV-2-SARS specific T cells from COVID-19 patients. We will compare the T response to the quality of the systemic and mucosal humoral response. Finally, we will evaluate in parallel two new biomarkers of the severity of COVID-19: plasma calprotectin and the presence of antibodies to type 1 IFN antibodies.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: ELISPOT; Diagnostic test: QUANTIFERON

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with COVID infection documented by PCR and/or antigenic testing will be included.

Description

Inclusion Criteria:

• Social security affiliation
• Signed informed consent
• Patients with COVID infection documented by PCR and/or antigenic testing

• Patients belonging to the following groups:

  • asymptomatic patients with PCR-positive PCR
  • patients with mild symptoms and PCR positive
  • seriously symptomatic patients with PCR positive
  • patients in resuscitation with positive PCR
  • Healthy individuals as controls

Exclusion Criteria:

• haemoglobin < 8g/dL
• Pregnancy, breastfeeding woman
• Patient vaccinated within 15 days prior to inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
asymptomatic patients; asymptomatic patients with PCR-positive PCR	Diagnostic test: ELISPOT; measure of immune response by ELISPOT; Diagnostic test: QUANTIFERON; measure of immune response by QUANTIFERON
mild symptoms patients; patients with mild symptoms and PCR positive	Diagnostic test: ELISPOT; measure of immune response by ELISPOT; Diagnostic test: QUANTIFERON; measure of immune response by QUANTIFERON
seriously symptomatic patients; seriously symptomatic patients with PCR positive	Diagnostic test: ELISPOT; measure of immune response by ELISPOT; Diagnostic test: QUANTIFERON; measure of immune response by QUANTIFERON
patients in resuscitation; patients in resuscitation with positive PCR	Diagnostic test: ELISPOT; measure of immune response by ELISPOT; Diagnostic test: QUANTIFERON; measure of immune response by QUANTIFERON
heathly volunteer; heathly volunteer as control	Diagnostic test: ELISPOT; measure of immune response by ELISPOT; Diagnostic test: QUANTIFERON; measure of immune response by QUANTIFERON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T cell immune response	Characterize T-cell immune response in patient with COVID 19 infection	from baseline to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cell immune response	Characterize B-cell immune response in patient with COVID 19 infection	from baseline to 18 months
Platelet immune response	Characterize platelet immune response in patient with COVID 19 infection	from baseline to 18 months
Immune response and chronic forms	Determine if there is a correlation between the pattern of immune response and the risk of reinfection or with persistence of symptoms in chronic forms of COVID-19.	from baseline to 18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Director: Stéphane Paul, PHD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; T cells; immune response; B cells
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20CH207; 2020-A02943-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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