Covid19
Conditions
Keywords
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.
Interventions
DRUGDexamethasone
Dexamethasone
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 | 28 days from study enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day Mortality | 28 days from study enrollment | All-cause mortality at 28 days after enrollment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone 20 mg Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
Dexamethasone: Dexamethasone | 52 |
| Dexamethasone 6 mg Dexamethasone 6 mg daily for 10 days
Dexamethasone: Dexamethasone | 55 |
| Total | 107 |
Baseline characteristics
| Characteristic | Dexamethasone 6 mg | Total | Dexamethasone 20 mg |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 17 | 57 years STANDARD_DEVIATION 16 | 56 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 32 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 15 Participants | 5 Participants |
| Race (NIH/OMB) White | 24 Participants | 53 Participants | 29 Participants |
| Sex: Female, Male Female | 26 Participants | 51 Participants | 25 Participants |
| Sex: Female, Male Male | 29 Participants | 56 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 52 | 5 / 55 |
| other Total, other adverse events | 6 / 52 | 10 / 55 |
| serious Total, serious adverse events | 1 / 52 | 2 / 55 |
Outcome results
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
Time frame: 28 days from study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 20 mg | Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 | 37 Participants |
| Dexamethasone 6 mg | Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 | 43 Participants |
Secondary
28-day Mortality
All-cause mortality at 28 days after enrollment
Time frame: 28 days from study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone 20 mg | 28-day Mortality | 11 Participants |
| Dexamethasone 6 mg | 28-day Mortality | 5 Participants |