NCT04707534

Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19

Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone

Timeline

• Start date: 2021-01-21
• Primary completion: 2021-12-31
• Completion: 2022-03-04
• First posted: 2021-01-13
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study