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

Study Overview
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: ELISPOT
* Diagnostic Test: QUANTIFERON


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| asymptomatic patients<br>asymptomatic patients with PCR-positive PCR | Diagnostic Test: ELISPOT<br>* measure of immune response by ELISPOT<br>Diagnostic Test: QUANTIFERON<br>* measure of immune response by QUANTIFERON<br>|
| mild symptoms patients<br>patients with mild symptoms and PCR positive | Diagnostic Test: ELISPOT<br>* measure of immune response by ELISPOT<br>Diagnostic Test: QUANTIFERON<br>* measure of immune response by QUANTIFERON<br>|
| seriously symptomatic patients<br>seriously symptomatic patients with PCR positive | Diagnostic Test: ELISPOT<br>* measure of immune response by ELISPOT<br>Diagnostic Test: QUANTIFERON<br>* measure of immune response by QUANTIFERON<br>|
| patients in resuscitation<br>patients in resuscitation with positive PCR | Diagnostic Test: ELISPOT<br>* measure of immune response by ELISPOT<br>Diagnostic Test: QUANTIFERON<br>* measure of immune response by QUANTIFERON<br>|
| heathly volunteer<br>heathly volunteer as control | Diagnostic Test: ELISPOT<br>* measure of immune response by ELISPOT<br>Diagnostic Test: QUANTIFERON<br>* measure of immune response by QUANTIFERON<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T cells, B cells, immune response, SARS-CoV-2