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

Phase 2

• Conditions: COVID19- Infection With SARS-CoV-2 Virus
• Interventions: Drug: Nivolumab Injection

• Registration Number: NCT04343144
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Last Update Submitted: 2020-04-12
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-14
• Study Start: 2020-04-15
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nivolumab	Nivolumab Injection	-

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement	day 14	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pneumologie hôpital Tenon; 🇫🇷 Paris, France