COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04558476

Misset Benoit

Not reported

2020-09-22

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age at least 18 years - hospitalization in an intensive care unit participating to the study - medical diagnosis with sars-cov-2 pneumonia as defined by both: - extended interstitial pneumonia on ct scan or a chest x-ray, consistent with viral pneumonia, within 10 days prior to inclusion - positive result of sars-cov-2 pcr test, or any emerging and validated diagnostic laboratory test for covid-19, within 15 days prior to inclusion - under mechanical ventilation administered through an endotracheal tube, for less than 5 days - prior clinical frailty scale < 6. - written consent of the patient, or - if impossible - of a relative acting as the legal representative, or - if impossible - of a physician from a non-participating department of the same hospital acting as an impartial witness .

- pregnancy - prior episode of transfusion-related side effect - medical decision to limit therapy - current participation in another trial testing a covid-19 therapy

2

University of Liege

18

100

Belgium

Critical disease at enrollment

8: Critical disease at enrollment

475

Vital status

None

Phase 2

[{"arm_notes": "", "treatment_id": 322, "treatment_name": "Convalescent plasma", "treatment_type": "Convalescent plasma", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]