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

Phase 4

Completed

• Conditions: Covid19
• Interventions: Drug: Dexamethasone

• Registration Number: NCT04707534
• Lead Sponsor: University of Oklahoma

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.

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 Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2021-01-21
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-04
• Results First Submitted: 2023-12-04
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-28
• Last Update Submitted: 2024-03-28
• Results First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone 6 mg	Dexamethasone	Dexamethasone 6 mg daily for 10 days
Dexamethasone 20 mg	Dexamethasone	Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28	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

Secondary Outcome Measures

Name	Time	Method
28-day Mortality	28 days from study enrollment	All-cause mortality at 28 days after enrollment

Trial Locations

Locations (1)

University of Oklahoma Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States