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

Purpose

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.

Condition

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 - Pregnancy - Patient on judicial protection

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dexamethasone 20 mg 		Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
  • Drug: Dexamethasone
    Dexamethasone
Active Comparator
Dexamethasone 6 mg 		Dexamethasone 6 mg daily for 10 days
  • Drug: Dexamethasone
    Dexamethasone

Recruiting Locations

More Details

NCT ID
NCT04707534
Status
Completed
Sponsor
University of Oklahoma

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.