Status:
COMPLETED
Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia
Lead Sponsor:
Scandinavian Critical Care Trials Group
Collaborating Sponsors:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Centre for Research in Intensive Care (CRIC)
Conditions:
Covid19
Hypoxia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia.
Detailed Description
Background: Preliminary results from the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial have reported a reduction in 28-day mortality with low-dose dexamethasone (6 mg) once daily versus n...
Eligibility Criteria
Inclusion
- All of the following 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
- We will exclude patients who fulfil any of the following 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 days consecutive 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
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04509973
Start Date
August 27 2020
End Date
February 1 2022
Last Update
February 24 2022
Active Locations (53)
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1
Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.
Aalborg, Denmark
2
Dept. of Intensive care, Aarhus University Hospital
Aarhus, Denmark
3
Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
4
Dept. of Neuroanaesthesiology
Copenhagen, Denmark, 2100