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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID19- Infection With SARS-CoV-2 Virus
• Intervention / Treatment: Drug: Nivolumab Injection

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacques Cadranel, MD PhD; Phone Number: +33 1 56 01 66 73; Email: jacques.cadranel@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Pneumologie hôpital Tenon
    • Contact: Jacques Cadranel, MD PhD; Phone Number: 01 56 01 66 73; Email: jacques.cadranel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nivolumab	Drug: Nivolumab Injection; Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
NO_INTERVENTION: Standard of Card

What is the study measuring?

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
Incidence of adverse events		day 28
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 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 15, 2020
• Primary Completion (ANTICIPATED): July 31, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (ACTUAL): April 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: APHP200389-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No