COVID19- Infection With SARS-CoV-2 Virus
Conditions
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.
Interventions
Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2 parallels arms randomized open-label multi center clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of ICU admission | day 28 | — |
| Length of hospital stay | day 90 | — |
| Positive nasal PCR | day 7 | — |
| Overall survival | day 28 | — |
| Incidence of grade 3-4 adverse events | day 28 | according to CTC AE-4.03 |
| World Health Organisation (WHO) progression scale | day 4, 7 and 14 | range, from 0 (healthy) to 10 (death) |
| Incidence of adverse events | day 28 | — |
Countries
France
Contacts
Primary ContactJacques Cadranel, MD PhD
Outcome results
None listed