Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2022-03-04

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.

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone 20 mg

Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone

Dexamethasone 6 mg

Dexamethasone 6 mg daily for 10 days

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone

Interventions

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Dexamethasone

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No