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

Last updated: July 13, 2020
Sponsor: Centre Hospitalier Universitaire de Besancon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Corona Virus

Treatment

N/A

Clinical Study ID

NCT04365322
2020/502
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Refusal to participate,

  • Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone orequivalent 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 followingexceptions:

  • Patients with a history of autoimmune-related hypothyroidism who are on thyroidreplacement hormone are eligible for the study,

  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimenare 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 forpatients in cohort C),

  • Previous prescribing of biotherapy or treatment for the management of COVID-19 is notan exclusion criterion,

  • Patient under guardianship, curatorship or under the protection of justice.

Study Design

Total Participants: 160
Study Start date:
April 20, 2020
Estimated Completion Date:
April 20, 2025

Connect with a study center

  • CHU Jean Minjoz

    Besançon, 25030
    France

    Active - Recruiting

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