Status:
COMPLETED
Randomized Open Investigation Determining Steroid Dose
Lead Sponsor:
Northwell Health
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04834375
Start Date
March 19 2021
End Date
March 29 2022
Last Update
July 20 2023
Active Locations (1)
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1
Northwell Health
New Hyde Park, New York, United States, 11042