Official Title
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
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 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.

Not yet recruiting
COVID19- Infection With SARS-CoV-2 Virus

Drug: Nivolumab Injection
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
Nivolumab

Eligibility Criteria

Inclusion Criteria:

- 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 Criteria:

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
France
Contacts

Jacques Cadranel, MD PhD
1 56 01 66 73 +33
jacques.cadranel@aphp.fr

Assistance Publique - Hôpitaux de Paris
NCT Number
MeSH Terms
Infection
Nivolumab