Randomized Open Investigation Determining Steroid Dose

• Status: Recruiting
• Trial end date: 2022-04-19
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

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