Back to resultsTrial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort. (CORIMUNO-NIVO)
Primary Purpose
COVID19- Infection With SARS-CoV-2 Virus
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Nivolumab Injection
Sponsored by
About this trial
This is an interventional treatment trial for COVID19- Infection With SARS-CoV-2 Virus
Eligibility 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
Sites / Locations
- Pneumologie hôpital Tenon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nivolumab
Standard of Card
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall survival
Overall survival
Cumulative incidence of ICU admission
Length of hospital stay
Positive nasal PCR
Incidence of adverse events
Incidence of grade 3-4 adverse events
according to CTC AE-4.03
World Health Organisation (WHO) progression scale
range, from 0 (healthy) to 10 (death)
Full Information
NCT ID
NCT04343144
First Posted
April 9, 2020
Last Updated
April 12, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04343144
Brief Title
Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
Acronym
CORIMUNO-NIVO
Official Title
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2020 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19- Infection With SARS-CoV-2 Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
2 parallels arms randomized open-label multi center clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab
Arm Type
Experimental
Arm Title
Standard of Card
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injection
Intervention Description
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
Primary Outcome Measure Information:
Title
Time to clinical improvement
Description
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 Outcome Measure Information:
Title
Overall survival
Time Frame
day 28
Title
Overall survival
Time Frame
day 90
Title
Cumulative incidence of ICU admission
Time Frame
day 28
Title
Length of hospital stay
Time Frame
day 90
Title
Positive nasal PCR
Time Frame
day 7
Title
Incidence of adverse events
Time Frame
day 28
Title
Incidence of grade 3-4 adverse events
Description
according to CTC AE-4.03
Time Frame
day 28
Title
World Health Organisation (WHO) progression scale
Description
range, from 0 (healthy) to 10 (death)
Time Frame
day 4, 7 and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques Cadranel, MD PhD
Phone
1 56 01 66 73
Ext
+33
Email
jacques.cadranel@aphp.fr
Facility Information:
Facility Name
Pneumologie hôpital Tenon
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Cadranel, MD PhD
Phone
01 56 01 66 73
Email
jacques.cadranel@aphp.fr
12. IPD Sharing Statement
Learn more about this trial
Trial Evaluating Efficacy and Safety of Nivolumab (Optivo®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort.
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