Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

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.

Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.

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)

All cause mortality at 28 days. Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge

Need for oxygen supplementation at hospital discharge Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.

Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired

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

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