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

Recruiting

• Conditions: SARS-CoV-2 Infection
• Interventions: Other: Additional biological samples

• Registration Number: NCT04365322
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Primary Completion: 2020-09-01
• Study Completion: 2025-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe COVID-19 infection	Additional biological samples	-
Light to moderate COVID-19 infection	Additional biological samples	-
Cancer patients with COVID-19 infection	Additional biological samples	-

Primary Outcome Measures

Name	Time	Method
Specific immune responses	During COVID-19 infection or one month after COVID-19 infection	Intensity and diversity of immune responses specific for SARS-COV-2

Trial Locations

Locations (1)

CHU Jean Minjoz; 🇫🇷 Besançon, France