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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.