Phase 4
N=110
Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04707534 ↗Enrolled (actual)
110
Serious AEs
2.8%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 — 37; 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 |
37; 43 | — |
| SECONDARY 28-day Mortality |
11; 5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04707534). 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.