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

SARS-CoV-2 Infection Clinical Trial

— COV-CREM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365322
• Other study ID #: 2020/502
• Status: Recruiting
• Start date: April 20, 2020
• Est. completion date: April 20, 2025

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Marie KROEMER, PharmD PhD
• Phone: 0370632281
• Email: mkroemer[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: April 20, 2025
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2 Infection

Intervention

Other:
• Additional biological samples
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific immune responses	Intensity and diversity of immune responses specific for SARS-COV-2	During COVID-19 infection or one month after COVID-19 infection