Randomized Open Investigation Determining Steroid Dose

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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)
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Standard dexamethasone dose 		Dexamethasone 6 mg IV daily for 10 days
Experimental
Weight-based dexamethasone dose 		Dexamethasone 0.2 mg/kg/day IV (maximum 20 mg daily) for 10 days
  • Drug: Weight-based dexamethasone dose
    Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure
    Other names:
    • Higher dexamethasone dose

Recruiting Locations

More Details

NCT ID
NCT04834375
Status
Completed
Sponsor
Northwell Health

Detailed 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.