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

University of Oklahoma110 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Covid19

Interventions

DexamethasoneDRUG

Dexamethasone

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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

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

Time frame: 28 days from study enrollment

Secondary Outcomes

28-day Mortality

All-cause mortality at 28 days after enrollment

Time frame: 28 days from study enrollment

Data from ClinicalTrials.gov

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