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

NCT04343144 | Unknown Phase 2 DMC

• 1 other identifier: APHP200389-5
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19- Infection With SARS-CoV-2 Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Nivolumab

EXPERIMENTAL

Drug: Nivolumab Injection

Standard of Card

NO INTERVENTION

Interventions

Nivolumab Injection DRUG

Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).

Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pneumologie hôpital Tenon

Paris, 75019, France

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jacques Cadranel, MD PhD

CONTACT

1 56 01 66 73; jacques.cadranel@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 parallels arms randomized open-label multi center clinical trial

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: April 15, 2020
• Primary Completion: July 31, 2020
• Study Completion: September 30, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Locations

FR (1)