Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.

• Status: Not yet recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Nivolumab

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