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

Covid19 Clinical Trial

Official title:

Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707534
• Other study ID #: 12927
• Status: Completed
• Phase: Phase 4
• Start date: January 21, 2021
• Est. completion date: March 4, 2022

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 4, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Dexamethasone
Dexamethasone

Locations

Country	Name	City	State
United States	University of Oklahoma Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days from study enrollment
Secondary	28-day Mortality	All-cause mortality at 28 days after enrollment	28 days from study enrollment