Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834375
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2021-03-31
Brief Title:
Randomized Open Investigation Determining Steroid Dose
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Randomized Open Investigation Determining Steroid Dose ROIDS-Dose
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROIDS-Dose
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 dexamethasone 6 mg to a higher weight-based dosing 02 mgkg 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 mgkgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None