COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46442

Dr Vivekanand Jha

vjha@georgeinstitute.org.in

2020-10-29

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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

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

2

Professor Anders Perner

18

100

India;Denmark

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

1500

Days alive without life support (i.e. invasive mechanical ventilation; circulatory support or renal replacement therapy) from randomisationTimepoint: Day 28

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

Phase 3

[{"arm_notes": "6mg", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "12mg", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]