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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID19- Infection With SARS-CoV-2 Virus

Intervention / Treatment
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* Drug: Nivolumab Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 parallels arms randomized open-label multi center clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab<br> | Drug: Nivolumab Injection<br>* Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).<br>|
| No Intervention: Standard of Card<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical improvement | the time required for clinical improvement, defined as the time elapsed between randomization and a two-point improvement on an ordinal scale with seven categories (WHO scale), or the discharge alive from hospital, whatever occurred first | day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | day 28 | 
| Overall survival |  | day 90 | 
| Cumulative incidence of ICU admission |  | day 28 | 
| Length of hospital stay |  | day 90 | 
| Positive nasal PCR |  | day 7 | 
| Incidence of adverse events |  | day 28 | 
| Incidence of grade 3-4 adverse events | according to CTC AE-4.03 | day 28 | 
| World Health Organisation (WHO) progression scale | range, from 0 (healthy) to 10 (death) | day 4, 7 and 14 |