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Dexamethasone for COVID-19

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ClinicalTrials.gov Identifier: NCT04707534
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
Actual Study Start Date : January 21, 2021
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : June 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone 20 mg
Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
Drug: Dexamethasone
Dexamethasone

Active Comparator: Dexamethasone 6 mg
Dexamethasone 6 mg daily for 10 days
Drug: Dexamethasone
Dexamethasone




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 28-day mortality [ Time Frame: 28 days from study enrollment ]
    All-cause mortality at 28 days after enrollment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707534


Contacts
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Contact: Huimin Wu, MD MPH (405) 271-6173 Huimin-Wu@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Huimin Wu, MD MPH    405-271-6173    huimin-wu@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04707534    
Other Study ID Numbers: 12927
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021

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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
Keywords provided by University of Oklahoma:
COVID 19
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents