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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04365322
Acronym
COV-CREM
Enrollment
160
Registered
2020-04-28
Start date
2020-04-20
Completion date
2025-04-20
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection

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.

Interventions

Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Specific immune responsesDuring COVID-19 infection or one month after COVID-19 infectionIntensity and diversity of immune responses specific for SARS-COV-2

Countries

France

Contacts

Primary ContactMarie KROEMER, PharmD PhD
mkroemer@chu-besancon.fr0370632281
Backup ContactKevin BOUILLER, MD
kbouiller@chu-besancon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026