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

Centre Hospitalier Universitaire de Besancon1 site in 1 country160 target enrollmentApril 20, 2020

ConditionsSARS-CoV-2 Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: SARS-CoV-2 Infection
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 160
Locations: 1
Primary Endpoint: Specific immune responses
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 20, 2020

End Date

April 20, 2025

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

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.