COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001395-15/DK

Department of Intensive Care, Rigshospitalet - Clinical Trials Information

anders.perner@regionh.dk

2020-03-30

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

All the following criteria must be fulfilled: - Aged 18 years or above AND - Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND - Use of one of the following: Invasive mechanical ventilation OR Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) OR Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system

We will exclude patients who fulfil any of the following criteria: - Use of systemic corticosteroids for any other indication than COVID-19 - Invasive mechanical ventilation for more than 48 hours - Invasive fungal infection - Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG - Known hypersensitivity to hydrocortisone - A patient for whom the clinical team has decided not to use invasive mechanical ventilation - Consent not obtainable

2

Deparment of Intensive Care, Rigshospitalet

18

None

Denmark

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

1000

Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28.

nan

Phase 3

[{"arm_notes": "", "treatment_id": 603, "treatment_name": "Hydrocortisone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]