Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

Northwell Health

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Drug: Weight-based dexamethasone dose

Study type: Interventional

Funder types: Other

Identifiers

NCT04834375

21-0171

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Standard dexamethasone dose

No Intervention group

Description:

Dexamethasone 6 mg IV daily for 10 days

Weight-based dexamethasone dose

Experimental group

Description:

Dexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days

Treatment:

Drug: Weight-based dexamethasone dose