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

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ClinicalTrials.gov Identifier: NCT04343144
Recruitment Status : Not yet recruiting
First Posted : April 13, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date April 14, 2020
Estimated Study Start Date  ICMJE April 15, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
Time to clinical improvement [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2020)
  • Overall survival [ Time Frame: day 28 ]
  • Overall survival [ Time Frame: day 90 ]
  • Cumulative incidence of ICU admission [ Time Frame: day 28 ]
  • Length of hospital stay [ Time Frame: day 90 ]
  • Positive nasal PCR [ Time Frame: day 7 ]
  • Incidence of adverse events [ Time Frame: day 28 ]
  • Incidence of grade 3-4 adverse events [ Time Frame: day 28 ]
    according to CTC AE-4.03
  • World Health Organisation (WHO) progression scale [ Time Frame: day 4, 7 and 14 ]
    range, from 0 (healthy) to 10 (death)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Overall survival [ Time Frame: day 28 ]
  • Overall survival [ Time Frame: day 90 ]
  • Cumulative incidence of ICU admission [ Time Frame: day 28 ]
  • Length of hospital stay [ Time Frame: day 90 ]
  • Positive nasal PCR [ Time Frame: day 7 ]
  • Incidence of adverse events [ Time Frame: day 28 ]
  • Incidence of grade 3-4 adverse events [ Time Frame: day 28 ]
    according to CTC AE-4.03
  • WHO scale [ Time Frame: day 4, 7 and 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
Official Title  ICMJE Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2 parallels arms randomized open-label multi center clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID19- Infection With SARS-CoV-2 Virus
Intervention  ICMJE Drug: Nivolumab Injection
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
Study Arms  ICMJE
  • Experimental: Nivolumab
    Intervention: Drug: Nivolumab Injection
  • No Intervention: Standard of Card
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
92
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jacques Cadranel, MD PhD 1 56 01 66 73 ext +33 jacques.cadranel@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343144
Other Study ID Numbers  ICMJE APHP200389-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP