Study of Specific Viral Immune Responses Induced by SARS-CoV-2 (COVID-19)
NCT ID: NCT04365322
Last Updated: 2020-07-14
Study Results
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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UNKNOWN
160 participants
OBSERVATIONAL
2020-04-20
2025-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Severe COVID-19 infection
Additional biological samples
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
Light to moderate COVID-19 infection
Additional biological samples
Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
Cancer patients with COVID-19 infection
Additional biological samples
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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CHU Jean Minjoz
Besançon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020/502
Identifier Type: -
Identifier Source: org_study_id
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