Dexamethasone for COVID-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone 20 mg<br>Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days | Drug: Dexamethasone<br>* Dexamethasone<br>|
| Active Comparator: Dexamethasone 6 mg<br>Dexamethasone 6 mg daily for 10 days | Drug: Dexamethasone<br>* Dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization ordinal scale at day 28 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days | Days being alive and free from mechanical ventilation at day 28 after enrollment. For patients who die, it is 0. | 28 days from study enrollment | 
| 28-day mortality | All-cause mortality at 28 days after enrollment | 28 days from study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID 19