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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone 20 mg | Experimental | Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days |
|
| Dexamethasone 6 mg | Active Comparator | Dexamethasone 6 mg daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day Mortality | All-cause mortality at 28 days after enrollment | 28 days from study enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huimin Wu, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36190994 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone 20 mg | Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone |
| FG001 | Dexamethasone 6 mg | Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone 20 mg | Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone |
| BG001 | Dexamethasone 6 mg | Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 28 days from study enrollment |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone 20 mg | Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventilator associated pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperglycemia, requires insulin infusion | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Clinical Trials | University of Oklahoma Health Sciences Center | 405-271-6173 | Dianne-Belshe@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2021 | Dec 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Dexamethasone 6 mg |
Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone |
|
|
| Secondary | 28-day Mortality | All-cause mortality at 28 days after enrollment | Posted | Count of Participants | Participants | 28 days from study enrollment |
|
|
|
| 11 |
| 52 |
| 1 |
| 52 |
| 6 |
| 52 |
| EG001 | Dexamethasone 6 mg | Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone | 5 | 55 | 2 | 55 | 10 | 55 |
| bacteremia | Infections and infestations | Systematic Assessment |
|
| Catheter-related bloodstream infection | Infections and infestations | Systematic Assessment |
|
| Candidemia | Infections and infestations | Systematic Assessment |
|
| Pulmonary aspergillosis | Infections and infestations | Systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |