Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Dexamethasone 12mg: Intervention period is up to 10 days from randomisation or until hospital discharge or death, whichever comes first.
Route: IV
Frequency: Once Daily
Control Intervention1: Dexamethasone 6mg: Intervention period is up to 10 days from randomisation or until hospital discharge or death, whichever comes first
Route: IV
Sponsors
Professor Anders Perner
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents Use of systemic corticosteroids for COVID-19 for 5 consecutive days or more Invasive fungal infection ctive tuberculosis Fertile woman ( Known hypersensitivity to dexamethasone Previously randomised into the COVID STEROID 2 trial Informed consent not obtainable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisationTimepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of participants with one or more serious adverse reactions (SARs) at day 28 defined as new episodes of septic shock, invasive fungal infection, clinically important gastrointestinal (GI) bleeding or anaphylactic reaction to IV dexamethasoneTimepoint: Day 28;All-cause mortalityTimepoint: Day 28 and Day 90;All-cause mortality at day 180Timepoint: Day 180;Days alive without life supportTimepoint: Day 90;HRQoL at using EQ-5D-5L and EQ-VASTimepoint: Day 180 | — |
Countries
Denmark, India
Contacts
Public ContactDr Vivekanand Jha
George Institute for Global Health
Outcome results
None listed