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

Centre Hospitalier Universitaire de Besancon

Status: Enrolling

Conditions: SARS-CoV-2 Infection

Treatments: Other: Additional biological samples

Study type: Observational

Funder types: Other

Identifiers

NCT04365322

2020/502

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

160 participants in 3 patient groups

Severe COVID-19 infection

Treatment:

Other: Additional biological samples

Light to moderate COVID-19 infection

Treatment:

Other: Additional biological samples

Cancer patients with COVID-19 infection

Treatment:

Other: Additional biological samples