Dexamethasone for COVID-19

• ClinicalTrials.gov Identifier: NCT04707534
• Recruitment Status: Completed
• First Posted: January 13, 2021
• Last Update Posted: March 11, 2022
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: January 11, 2021
• First Posted Date: January 13, 2021
• Last Update Posted Date: March 11, 2022
• Actual Study Start Date: January 21, 2021
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2021)

World Health Organization ordinal scale at day 28 [ Time Frame: 28 days from study enrollment ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 12, 2021)

• Ventilator-free days [ Time Frame: 28 days from study enrollment ]
  Days being alive and free from mechanical ventilation at day 28 after enrollment. For patients who die, it is 0.
• 28-day mortality [ Time Frame: 28 days from study enrollment ]
  All-cause mortality at 28 days after enrollment

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexamethasone for COVID-19
• Official Title: Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

Drug: Dexamethasone

Dexamethasone

Study Arms

• Experimental: Dexamethasone 20 mg
  Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
  Intervention: Drug: Dexamethasone
• Active Comparator: Dexamethasone 6 mg
  Dexamethasone 6 mg daily for 10 days
  Intervention: Drug: Dexamethasone

• Publications *: Wu H, Daouk S, Kebbe J, Chaudry F, Harper J, Brown B. Low-dose versus high-dose dexamethasone for hospitalized patients with COVID-19 pneumonia: A randomized clinical trial. PLoS One. 2022 Oct 3;17(10):e0275217. doi: 10.1371/journal.pone.0275217. eCollection 2022.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2022): 110
• Original Estimated Enrollment (submitted: January 12, 2021): 300
• Actual Study Completion Date: March 4, 2022
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04707534
• Other Study ID Numbers: 12927
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Oklahoma
• Verification Date: March 2022