Skip to main content
OpenTrials
Completed

NCT Number: NCT04834375

Randomized Open Investigation Determining Steroid Dose

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwell Health

New Hyde Park, New York, 11042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weight-based dexamethasone dose

Drug

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

Other names: Higher dexamethasone dose

Primary outcomes

  1. All Cause Mortality at 28 Days

    Time frame: 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

Secondary outcomes

  1. Number of Participants Admitted to the ICU

    Time frame: 28 days

    Number of participants that required admission to the ICU

  2. Days of Stay in the Intensive Care Unit

    Time frame: 28 days

    ICU length of stay

  3. Days of Hospitalization

    Time frame: 28 days

    Duration of hospitalization

  4. Number of Participants That Required Higher Levels of Oxygen Supplementation

    Time frame: 28 days

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

  5. Number of Participants That Required Invasive Mechanical Ventilation

    Time frame: 28 days

    Escalation to invasive mechanical ventilation

  6. Duration of Invasive Mechanical Ventilation

    Time frame: 28 days

    Total days requiring invasive mechanical ventilation

  7. Number of Participants That Required ECMO

    Time frame: 28 days

    Refractory hypoxemia requiring ECMO

  8. Number of Participants That Required Tracheostomy

    Time frame: 28 days

    Need for tracheostomy

  9. Number of Participants That Developed Secondary Bacterial or Fungal Infections

    Time frame: 28 days

    Culture positive evidence of secondary bacterial or fungal infections

  10. Number of Participants That Developed Clinically Significant Hyperglycemia

    Time frame: 28 days

    Defined as need for insulin drip or ICU admission to control hyperglycemia

  11. Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital

    Time frame: Until hospital discharge

    Need for oxygen supplementation at hospital discharge

    Comment: Corrected total number of discharged patients alive to 55 in the "Standard Dexamethasone Dose" Arm.

  12. Subjective Symptoms at 28 Days

    Time frame: 28 days

    Subjective symptoms questionnaire at 28 days

  13. Disposition Upon Discharge

    Time frame: At hospital discharge

    Home, home with physical therapy, other (skilled nursing facility, long-term acute care facility, long-term care facility / nursing home, acute rehabilitation facility, hospice care), expired

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose)

Acronym: ROIDS-Dose

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2021
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.