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

NCT ID: NCT04365322

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2025-04-20

Brief Summary

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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

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Conditions

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SARS-CoV-2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Severe COVID-19 infection

Additional biological samples

Intervention Type OTHER

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

Light to moderate COVID-19 infection

Additional biological samples

Intervention Type OTHER

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

Cancer patients with COVID-19 infection

Additional biological samples

Intervention Type OTHER

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

Interventions

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Additional biological samples

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

Intervention Type OTHER

Other Intervention Names

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Additional blood samples will be realized as part of the care

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Jean Minjoz

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie KROEMER, PharmD PhD

Role: CONTACT

0370632281

Kevin BOUILLER, MD

Role: CONTACT

Facility Contacts

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Marie KROEMER, PharmD PhD

Role: primary

Kevin BOUILLER, MD

Role: backup

Other Identifiers

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2020/502

Identifier Type: -

Identifier Source: org_study_id

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