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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343144
Recruitment Status : Unknown
Verified April 2020 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  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

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID19- Infection With SARS-CoV-2 Virus Drug: Nivolumab Injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
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
Official Title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 [ Time Frame: day 28 ]
    according to CTC AE-4.03

  8. World Health Organisation (WHO) progression scale [ Time Frame: day 4, 7 and 14 ]
    range, from 0 (healthy) to 10 (death)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343144


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

Locations
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France
Pneumologie hôpital Tenon
Paris, France, 75019
Contact: Jacques Cadranel, MD PhD    01 56 01 66 73    jacques.cadranel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04343144    
Other Study ID Numbers: APHP200389-5
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action