NCT04834375

Randomized Open Investigation Determining Steroid Dose

Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Weight-based dexamethasone dose	Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure

Timeline

• Start date: 2021-03-19
• Primary completion: 2022-01-25
• Completion: 2022-03-29
• First posted: 2021-04-08
• Last updated: 2023-07-20
• Results posted: 2023-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study