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Corticosteroid
Dexamethasone 20 mg for Coronavirus
Phase 4
Waitlist Available
Led By Huimin Wu, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days from study enrollment
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
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.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days from study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days from study enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28
Secondary study objectives
28-day Mortality
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dexamethasone 20 mgExperimental Treatment1 Intervention
Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days
Group II: Dexamethasone 6 mgActive Control1 Intervention
Dexamethasone 6 mg daily for 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,571 Total Patients Enrolled
Huimin Wu, MDPrincipal InvestigatorUniversity of Oklahoma
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