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

University of Oklahoma (OU)

Status and phase: Completed; Phase 4

Conditions: Covid19

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04707534

12927

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Dexamethasone 20 mg

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Dexamethasone 6 mg

Active Comparator group

Description:

Dexamethasone 6 mg daily for 10 days

Treatment:

Drug: Dexamethasone