Dexamethasone for COVID-19
This open label clinical trial is to evaluate two different doses of dexamethasone on the health outcome using World Health Organization ordinal scale at day 28 in hospitalized patients with COVID-19.
The coronavirus disease 2019 (COVID-19) pandemic is a serious global health threat. Multiple antiviral or immunomodulatory therapies have failed to show any mortality benefit for patients with COVID-19. Dexamethasone was shown in prior studies to improve mortality and ventilator free days. However, it is unclear what dose of dexamethasone is most beneficial in hospitalized patients with COVID-19. This randomized single center open label clinical trial is to evaluate two different doses of dexamethasone (20mg vs. 6mg) on the health outcome for hospitalized patients with COVID-19. The intervention arm is dexamethasone 20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. The comparator is dexamethasone 6mg daily for 10 days. Three hundred participants will be enrolled. The primary outcome is clinical improvement using World Health Organization ordinal scale at day 28.
Arms and Interventions
|Experimental: Dexamethasone 20 mg
Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
|Active Comparator: Dexamethasone 6 mg
Dexamethasone 6 mg daily for 10 days
Primary Outcome Measures
- World Health Organization ordinal scale at day 28 [28 days from study enrollment]
1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen by mask or nasal prongs 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation 7. Hospitalized, on invasive mechanical ventilation + additional organ support (pressors, RRT, ECMO) 8. Death
Secondary Outcome Measures
- Ventilator-free days [28 days from study enrollment]
Days being alive and free from mechanical ventilation at day 28 after enrollment. For patients who die, it is 0.
- 28-day mortality [28 days from study enrollment]
All-cause mortality at 28 days after enrollment
Age ≥ 18 years old
RT-PCR confirmed COVID-19 infection
Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) or need supplemental oxygen with oxygen mask or nasal cannula
Underlying disease requiring chronic corticosteroids
Severe adverse events before admission, i.e. cardiac arrest;
Contraindication for corticosteroids;
Death is deemed to be imminent and inevitable during the next 24 hours
Recruited in other clinical intervention trial
Patient on judicial protection
Contacts and Locations
|1||University of Oklahoma Medical Center||Oklahoma City||Oklahoma||United States||73104|
Sponsors and Collaborators
- University of Oklahoma
Study Documents (Full-Text)None provided.