Dexamethasone for COVID-19

University of Oklahoma (Other)
Overall Status
Completed ID

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Actual Enrollment :
110 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
Actual Study Start Date :
Jan 21, 2021
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Mar 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexamethasone 20 mg

Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days

Drug: Dexamethasone

Active Comparator: Dexamethasone 6 mg

Dexamethasone 6 mg daily for 10 days

Drug: Dexamethasone

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 28-day mortality [28 days from study enrollment]

    All-cause mortality at 28 days after enrollment

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 University of Oklahoma Medical Center Oklahoma City Oklahoma United States 73104

Sponsors and Collaborators

  • University of Oklahoma


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
University of Oklahoma Identifier:
Other Study ID Numbers:
  • 12927
First Posted:
Jan 13, 2021
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by University of Oklahoma
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022