Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

21-0171

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.

2021-03-19

2022-01-25

2022-03-29

Completed

Early phase I

142

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a parallel fashion into either the standard dexamethasone dose of 6 mg or weight-based dexamethasone of 0.2 mg/kg (maximum dose of 20 mg)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 142, 'type': 'ACTUAL'}}

2023-07-20