Phase 3
N=142
Randomized Open Investigation Determining Steroid Dose
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04834375 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: All Cause Mortality at 28 Days — 15; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Weight-based dexamethasone dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Mortality at 28 Days |
15; 12 | — |
| SECONDARY Number of Participants Admitted to the ICU |
27; 12 | — |
| SECONDARY Days of Stay in the Intensive Care Unit |
15.33; 11.33 | — |
| SECONDARY Days of Hospitalization |
14.83; 11.56 | — |
| SECONDARY Number of Participants That Required Higher Levels of Oxygen Supplementation |
32; 31 | — |
| SECONDARY Number of Participants That Required Invasive Mechanical Ventilation |
19; 10 | — |
| SECONDARY Duration of Invasive Mechanical Ventilation |
19.95; 10.90 | — |
| SECONDARY Number of Participants That Required ECMO |
3; 2 | — |
| SECONDARY Number of Participants That Required Tracheostomy |
5; 1 | — |
| SECONDARY Number of Participants That Developed Secondary Bacterial or Fungal Infections |
19; 9 | — |
| SECONDARY Number of Participants That Developed Clinically Significant Hyperglycemia |
5; 4 | — |
| SECONDARY Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital |
25; 27 | — |
| SECONDARY Subjective Symptoms at 28 Days |
33; 44; 3; 2 | — |
| SECONDARY Disposition Upon Discharge |
40; 42; 10; 11; 5; 5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Adults greater or equal than 18 years old
- COVID-19 infection confirmed by positive PCR test
- Hypoxemia defined by an oxygen saturation 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
Data sourced from ClinicalTrials.gov (NCT04834375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.