Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)

Study Overview
=================
Brief Summary
-----------------
SARS-CoV-2, has caused an international outbreak of respiratory illness termed Covid-19. The investigators used peptides derived from SARS-CoV-2 virus, to study viral-specific immune responses. COV-CREM is a French prospective monocentric study that will evaluate viral-specific cell responses in positive patients for SARS-CoV-2 on the basis of (RT-PCR) assay performed in respiratory tract sample tested by our local Center for Disease Control.

Official Title
-----------------
Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires

Conditions
-----------------
SARS-CoV-2 Infection

Intervention / Treatment
-----------------
* Other: Additional biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 PCR positive, Hospitalized patients with illness of any duration, and/or SpO2 ≤ 92% on room air. Cohorte C : patients with cancer (hematological malignancies and solid tumors). Exclusion Criteria: Refusal to participate, Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study, Active or chronic hepatitis B or C and/or HIV positive (HIV 1/2 antibodies patients), or a known history of active Tuberculosis bacillus, Active autoimmune disease that required a systemic treatment, with the following exceptions: Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study, Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study, Prior allogeneic bone marrow transplantation or prior solid organ transplantation, Patients currently exposed to chemotherapy, anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy or biotherapy (except for patients in cohort C), Previous prescribing of biotherapy or treatment for the management of COVID-19 is not an exclusion criterion, Patient under guardianship, curatorship or under the protection of justice.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe COVID-19 infection<br> | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.<br>* Other names: Additional blood samples will be realized as part of the care;|
| Light to moderate COVID-19 infection<br> | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.<br>* Other names: Additional blood samples will be realized as part of the care;|
| Cancer patients with COVID-19 infection<br> | Other: Additional biological samples<br>* Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.<br>* Other names: Additional blood samples will be realized as part of the care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific immune responses | Intensity and diversity of immune responses specific for SARS-COV-2 | During COVID-19 infection or one month after COVID-19 infection |