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 : 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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 parallels arms randomized open-label multi center clinical trial|
|Masking:||None (Open Label)|
|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|
Drug: Nivolumab Injection
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
|No Intervention: Standard of Card|
- 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
- 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)
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
|Contact: Jacques Cadranel, MD PhD||1 56 01 66 73 ext +firstname.lastname@example.org|
|Pneumologie hôpital Tenon|
|Paris, France, 75019|
|Contact: Jacques Cadranel, MD PhD 01 56 01 66 73 email@example.com|