COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003363-25/DK

Department of Intensive Care, Rigshospitalet - Clinical Trials Information

covid-steroid@cric.nu

2020-07-17

Completed

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) for hypoxia 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 in doses higher than 6 mg dexamethasone equivalents for other indications than COVID-19 - Use of systemic corticosteroids for COVID-19 for 5 days or more - Invasive fungal infection - Active tuberculosis - Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG - Known hypersensitivity to dexamethasone - Previously randomised into the COVID STEROID 2 trial - Informed consent not obtainable

3

Department of Intensive Care, Rigshospitalet

18

100

India;Sweden;Denmark

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

100

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

Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "low dose", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "high dose", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]