Clinical trial NCT04343144: Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
Official title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID19- Infection With SARS-CoV-2 Virus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallels arms randomized open-label multi center clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to clinical improvement
timeFrame: day 14
Secondary outcomes:
measure: Overall survival
timeFrame: day 28
measure: Overall survival
timeFrame: day 90
measure: Cumulative incidence of ICU admission
timeFrame: day 28
measure: Length of hospital stay
timeFrame: day 90
measure: Positive nasal PCR
timeFrame: day 7
measure: Incidence of adverse events
timeFrame: day 28
measure: Incidence of grade 3-4 adverse events
timeFrame: day 28
measure: World Health Organisation (WHO) progression scale
timeFrame: day 4, 7 and 14
Other outcomes:
Locations:
city: Paris
country: France
facility: Pneumologie hôpital Tenon
Study officials:
References: