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

Assistance Publique - Hôpitaux de Paris

Status and phase

Unknown

Phase 2

Conditions

COVID19- Infection With SARS-CoV-2 Virus

Treatments

Drug: Nivolumab Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT04343144

APHP200389-5

Details and patient eligibility

About

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.

Enrollment

92 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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