Northwell Health
New Hyde Park, New York, 11042, United States
NCT Number: NCT04834375
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
New Hyde Park, New York, 11042, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure
Other names: Higher dexamethasone dose
Time frame: 28 days
All cause mortality at 28 days.
Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge
Time frame: 28 days
Number of participants that required admission to the ICU
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Duration of hospitalization
Time frame: 28 days
Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation
Time frame: 28 days
Escalation to invasive mechanical ventilation
Time frame: 28 days
Total days requiring invasive mechanical ventilation
Time frame: 28 days
Refractory hypoxemia requiring ECMO
Time frame: 28 days
Need for tracheostomy
Time frame: 28 days
Culture positive evidence of secondary bacterial or fungal infections
Time frame: 28 days
Defined as need for insulin drip or ICU admission to control hyperglycemia
Time frame: Until hospital discharge
Need for oxygen supplementation at hospital discharge
Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.
Time frame: 28 days
Subjective symptoms questionnaire at 28 days
Time frame: At hospital discharge
Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired
Northwell Health
Other
Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)
Acronym: ROIDS-Dose
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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