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

NCT04648709 | Terminated

• 2 other identifiers: 20CH2072020-A02943-36
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

T cells; B cells; immune response; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• T cell immune response

  Characterize T-cell immune response in patient with COVID 19 infection

  from baseline to 18 months

Secondary Outcomes (3)

• B cell immune response

  from baseline to 18 months

• Platelet immune response

  from baseline to 18 months

• Immune response and chronic forms

  from baseline to 18 months

Study Arms (5)

asymptomatic patients

asymptomatic patients with PCR-positive PCR

Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON

mild symptoms patients

patients with mild symptoms and PCR positive

Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON

seriously symptomatic patients

seriously symptomatic patients with PCR positive

Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON

patients in resuscitation

patients in resuscitation with positive PCR

Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON

heathly volunteer

heathly volunteer as control

Diagnostic Test: ELISPOT; Diagnostic Test: QUANTIFERON

Interventions

ELISPOT DIAGNOSTIC_TEST

measure of immune response by ELISPOT

asymptomatic patients; heathly volunteer; mild symptoms patients; patients in resuscitation; seriously symptomatic patients

QUANTIFERON DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

asymptomatic patients; heathly volunteer; mild symptoms patients; patients in resuscitation; seriously symptomatic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• haemoglobin \< 8g/dL
• Pregnancy, breastfeeding woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

COVID-19

Interventions

Enzyme-Linked Immunospot Assay

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Enzyme-Linked Immunosorbent Assay; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Stéphane Paul, PHD

  CHU SAINT-ETIENNE

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 1, 2020
• Study Start: March 9, 2021
• Primary Completion: September 26, 2022
• Study Completion: December 11, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)