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 the efficacy and safety of OPTIVO® (nivolumab) COVID-19 patients hospitalized in conventional unit. The purpose of this study is to show the efficacy of nivolumab in patients with COVID-19 in combination with standard treatments. A phase 2 randomized open trial will evaluate the efficacy and safety of optivo® (nivolumab) alone versus standard of care (SoC) in patients hospitalized in conventional units. Patients will be randomly allocated 1:1 to either nivolumab or SoC.
Drug: Nivolumab Injection
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
- 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
- Patients with active cancer and immunocopromised patients
- Known hypersensitivity to nivolumab or to any of their excipients.
- 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
Jacques Cadranel, MD PhD
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