Randomized Open Investigation Determining Steroid Dose

Completed · Phase 3

Conditions studied: Covid19

In brief

Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.

Key facts

Study ID

NCT04834375

Run by

Northwell Health

People needed

142

Starts

2021-03-19

Expected to finish

2022-03-29

Last updated by the study team

2023-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults greater or equal than 18 years old
• COVID-19 infection confirmed by positive PCR test
• Hypoxemia defined by an oxygen saturation < 94% or the need for supplemental oxygen

You may not qualify if…

• Corticosteroid use for > 48h within the past 15 days prior to enrollment
• Use of steroids with doses higher than the equivalent to dexamethasone 6 mg
• Use of immunosuppressive drugs
• Pregnant women
• Chronic oxygen use
• Known history of dexamethasone allergy
• DNR / DNI
• Patient or proxy cannot consent

Where it is running

• Northwell Health — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

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