COVID19- Infection With SARS-CoV-2 Virus Clinical Trial
— CORIMUNO-NIVOOfficial title:
Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19-Nivolumab Trial
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.
| Status | Not yet recruiting |
| Enrollment | 92 |
| Est. completion date | September 30, 2020 |
| Est. primary completion date | July 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Pneumologie hôpital Tenon | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | day 14 | |
| Secondary | Overall survival | day 28 | ||
| Secondary | Overall survival | day 90 | ||
| Secondary | Cumulative incidence of ICU admission | day 28 | ||
| Secondary | Length of hospital stay | day 90 | ||
| Secondary | Positive nasal PCR | day 7 | ||
| Secondary | Incidence of adverse events | day 28 | ||
| Secondary | Incidence of grade 3-4 adverse events | according to CTC AE-4.03 | day 28 | |
| Secondary | World Health Organisation (WHO) progression scale | range, from 0 (healthy) to 10 (death) | day 4, 7 and 14 |