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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT04343144
Phase
PHASE2
Status
Unknown

Conditions

  • COVID19- Infection With SARS-CoV-2 Virus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 15, 2020
Status verified
Apr 2020
Primary completion
Jul 31, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
  • No Intervention: Standard of Card

Primary Outcome Measure

Time to clinical improvement [ Time Frame: day 14 ]

Central Contacts