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

NCT ID: NCT04648709

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2023-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Keywords

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T cells B cells immune response SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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asymptomatic patients

asymptomatic patients with PCR-positive PCR

ELISPOT

Intervention Type DIAGNOSTIC_TEST

measure of immune response by ELISPOT

QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

mild symptoms patients

patients with mild symptoms and PCR positive

ELISPOT

Intervention Type DIAGNOSTIC_TEST

measure of immune response by ELISPOT

QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

seriously symptomatic patients

seriously symptomatic patients with PCR positive

ELISPOT

Intervention Type DIAGNOSTIC_TEST

measure of immune response by ELISPOT

QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

patients in resuscitation

patients in resuscitation with positive PCR

ELISPOT

Intervention Type DIAGNOSTIC_TEST

measure of immune response by ELISPOT

QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

heathly volunteer

heathly volunteer as control

ELISPOT

Intervention Type DIAGNOSTIC_TEST

measure of immune response by ELISPOT

QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

measure of immune response by QUANTIFERON

Interventions

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ELISPOT

measure of immune response by ELISPOT

Intervention Type DIAGNOSTIC_TEST

QUANTIFERON

measure of immune response by QUANTIFERON

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Paul, PHD

Role: STUDY_DIRECTOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02943-36

Identifier Type: OTHER

Identifier Source: secondary_id

20CH207

Identifier Type: -

Identifier Source: org_study_id