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

March 28, 2024 updated by: University of Oklahoma

Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Dexamethasone
Active Comparator: Dexamethasone 6 mg
Dexamethasone 6 mg daily for 10 days
Drug: Dexamethasone
Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28
Time Frame: 28 days from study enrollment
the clinical improvement of greater than or equal to 2 points using the WHO-OSCI. 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
28 days from study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28-day Mortality
Time Frame: 28 days from study enrollment
All-cause mortality at 28 days after enrollment
28 days from study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Huimin Wu, MD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12927

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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