COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04343144

Jacques Cadranel, MD PhD

jacques.cadranel@aphp.fr

2020-04-13

Not reported

RCT

Randomized

Parallel

Open label

single-center

Treatment

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

- 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

2

Assistance Publique - Hôpitaux de Paris

18

None

France

Moderate disease at enrollment

3: Moderate disease at enrollment

92

Time to clinical improvement

None

Phase 2

[{"arm_notes": "", "treatment_id": 895, "treatment_name": "Nivolumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]