Randomized Open Investigation Determining Steroid Dose

Northwell Health142 enrolled

Overview

Dexamethasone has been approved for the treatment of severe COVID-19, but higher doses of steroids may be more effective. The purpose of this research study is to compare the current standard dose of dexamethasone 6 mg to a higher, weight-based dosing (0.2 mg/kg with maximum dose of 20 mg) to determine if it would be more effective against COVID-19 pneumonia.

Treatment for COVID-19 patients with respiratory failure has been vexing, but the use of steroids has shown promise. In a recent randomized control trial, dexamethasone 6 mg once daily showed a modest decrease in mortality among hospitalized COVID-19 patients who require oxygen supplementation or invasive mechanical ventilation. Other trials have shown that the inflammatory response to COVID-19 can be further attenuated at higher dosages of dexamethasone. These higher dosages have not been well studied and have not been directly compared to the current standard dose of dexamethasone 6 mg daily. We propose that a higher dexamethasone dose, equivalent to methylprednisolone 1 mg/kg/day which is routinely used to treat other inflammatory conditions of the lungs, may be more effective than the current standard dose in reducing mortality in COVID-19 patients with respiratory failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Covid19

Interventions

Weight-based dexamethasone doseDRUG

Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults greater or equal than 18 years old * COVID-19 infection confirmed by positive PCR test * Hypoxemia defined by an oxygen saturation \< 94% or the need for supplemental oxygen Exclusion Criteria: * Corticosteroid use for \> 48h within the past 15 days prior to enrollment * Use of steroids with doses higher than the equivalent to dexamethasone 6 mg * Use of immunosuppressive drugs * Pregnant women * Chronic oxygen use * Known history of dexamethasone allergy * DNR / DNI * Patient or proxy cannot consent

Locations (1)

Northwell Health

New Hyde Park, New York, United States

Outcomes

Primary Outcomes

All Cause Mortality at 28 Days

All cause mortality at 28 days. Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge

Time frame: 28 days

Secondary Outcomes

Number of Participants Admitted to the ICU

Number of participants that required admission to the ICU

Time frame: 28 days

Days of Stay in the Intensive Care Unit

ICU length of stay

Time frame: 28 days

Days of Hospitalization

Duration of hospitalization

Time frame: 28 days

Number of Participants That Required Higher Levels of Oxygen Supplementation

Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation

Time frame: 28 days

Number of Participants That Required Invasive Mechanical Ventilation

Escalation to invasive mechanical ventilation

Time frame: 28 days

Duration of Invasive Mechanical Ventilation

Total days requiring invasive mechanical ventilation

Time frame: 28 days

Number of Participants That Required ECMO

Refractory hypoxemia requiring ECMO

Data from ClinicalTrials.gov

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