Status:
UNKNOWN
Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
COVID19- Infection With SARS-CoV-2 Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
It appears interesting to use nivolumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU. This protocol CORIMUNO19-NIVO therefore, will evaluate th...
Eligibility Criteria
Inclusion
- Adults (men and women) age over 18 years old
- At least one nasal swab positive for COVID-19 detected by PCR, maximum 7 days prior to treatment
- Viral pneumonia confirmed by TDM scan
- Patients meeting all of the following 3 criteria:
- Requiring more than 3L/min of oxygen
- WHO progression scale = 5
- No NIV or High flow
Exclusion
- Patients with active cancer and immunocopromised patients
- Known hypersensitivity to nivolumab or to any of their excipients.
- Pregnancy
- Patient with an autoimmune or inflammatory disease (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease). Patients with thyroiditis or vitiligo only could be included.
- Patient with a history of thymoma
- Patient with a history of solid organ transplantation or a bone marrow transplantation
- Patients treated with immune checkpoint inhibitors 3 months prior to the study
- Patients who had a history of grade 3 or 4 immune-related adverse events with a previous treatment with immune-checkpoint inhibtors
- Patients requiring ICU based on Criteria of severity of COVID pneumopathy
- Respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04343144
Start Date
April 15 2020
End Date
September 30 2020
Last Update
April 14 2020
Active Locations (1)
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1
Pneumologie hôpital Tenon
Paris, France, 75019