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Status unknownNCT04343144CORIMUNO-NIVOUpdated Apr 14, 2020

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

A Phase 2 interventional study of Nivolumab Injection in COVID19- Infection With SARS-CoV-2 Virus, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-14.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • COVID19- Infection With SARS-CoV-2 Virus
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 92 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Nivolumab

    Drug: Nivolumab Injection

  • No intervention
    Standard of Card

Interventions

  • DrugNivolumab Injection

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

06

What researchers measure

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

    Time frame: day 14

Secondary outcomes

  1. Overall survival

    Time frame: day 28

  2. Overall survival

    Time frame: day 90

  3. Cumulative incidence of ICU admission

    Time frame: day 28

  4. Length of hospital stay

    Time frame: day 90

  5. Positive nasal PCR

    Time frame: day 7

  6. Incidence of adverse events

    Time frame: day 28

  7. Incidence of grade 3-4 adverse events

    according to CTC AE-4.03

    Time frame: day 28

  8. World Health Organisation (WHO) progression scale

    range, from 0 (healthy) to 10 (death)

    Time frame: day 4, 7 and 14

07

Study locations

1 site
  • Pneumologie hôpital Tenon
    Paris, 75019, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04343144
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 13, 2020
Start date
Apr 15, 2020 (estimated)
Primary completion
Jul 31, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Apr 14, 2020

Study contacts

Jacques Cadranel, MD PhD
Contact
jacques.cadranel@aphp.fr
1 56 01 66 73 ext. +33

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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