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

NCT04365322 | Unknown

• 1 other identifier: 2020/502
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Severe COVID-19 infection

Other: Additional biological samples

Light to moderate COVID-19 infection

Other: Additional biological samples

Cancer patients with COVID-19 infection

Other: Additional biological samples

Interventions

Additional biological samples OTHER

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

Also known as: Additional blood samples will be realized as part of the care

Cancer patients with COVID-19 infection; Light to moderate COVID-19 infection; Severe COVID-19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID-19 or convalescent.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Jean Minjoz

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Marie KROEMER, PharmD PhD

CONTACT

0370632281; mkroemer@chu-besancon.fr

Kevin BOUILLER, MD

CONTACT

kbouiller@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: April 20, 2020
• Primary Completion: September 1, 2020
• Study Completion: April 20, 2025
• Last Updated: July 14, 2020

Record last verified: 2020-05

Locations

FR (1)