- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04365322
Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19) (COV-CREM)
July 13, 2020 updated by: Centre Hospitalier Universitaire de Besancon
Étude Des réponses Immunitaires Lymphocytaires spécifiques Chez Des Patients infectés Par le Virus SARS-CoV-2 : Caractéristiques Des Réponses Effectrices et Mémoires
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie KROEMER, PharmD PhD
- Phone Number: 0370632281
- Email: mkroemer@chu-besancon.fr
Study Contact Backup
- Name: Kevin BOUILLER, MD
- Email: kbouiller@chu-besancon.fr
Study Locations
-
-
-
Besançon, France, 25030
- Recruiting
- CHU Jean Minjoz
-
Contact:
- Kevin BOUILLER, MD
- Email: kbouiller@chu-besancon.fr
-
Contact:
- Marie KROEMER, PharmD PhD
- Email: mkroemer@chu-besancon.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with COVID-19 or convalescent.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe COVID-19 infection
|
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
Other Names:
|
Light to moderate COVID-19 infection
|
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
Other Names:
|
Cancer patients with COVID-19 infection
|
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific immune responses
Time Frame: During COVID-19 infection or one month after COVID-19 infection
|
Intensity and diversity of immune responses specific for SARS-COV-2
|
During COVID-19 infection or one month after COVID-19 infection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2020
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
April 20, 2025
Study Registration Dates
First Submitted
April 25, 2020
First Submitted That Met QC Criteria
April 25, 2020
First Posted (Actual)
April 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/502
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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