Trial Outcomes & Findings for Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19 (NCT NCT04707534)

Last Updated: 2024-03-29

Results Overview

the clinical improvement of greater than or equal to 2 points using the WHO-OSCI. 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen by mask or nasal prongs 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation 7. Hospitalized, on invasive mechanical ventilation + additional organ support (pressors, RRT, ECMO) 8. Death

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

28 days from study enrollment

Results posted on

2024-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone 20 mg Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone
Overall Study STARTED	55	55
Overall Study Dexamethasone 20mg	52	0
Overall Study Dexamethasone 6mg	0	55
Overall Study COMPLETED	52	55
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing the Effects of Different Doses of Dexamethasone to Treat Inpatient COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone 20 mg n=52 Participants Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg n=55 Participants Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone	Total n=107 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 14 • n=5 Participants	58 years STANDARD_DEVIATION 17 • n=7 Participants	57 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days from study enrollment

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=52 Participants Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg n=55 Participants Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone
Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28	37 Participants	43 Participants

SECONDARY outcome

Timeframe: 28 days from study enrollment

All-cause mortality at 28 days after enrollment

Outcome measures

Outcome measures
Measure	Dexamethasone 20 mg n=52 Participants Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg n=55 Participants Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone
28-day Mortality	11 Participants	5 Participants

Adverse Events

Dexamethasone 20 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 11 deaths

Dexamethasone 6 mg

Serious events: 2 serious events

Other events: 10 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Dexamethasone 20 mg n=52 participants at risk Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg n=55 participants at risk Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone
Respiratory, thoracic and mediastinal disorders Ventilator associated pneumonia	1.9% 1/52 • 28 days	3.6% 2/55 • 28 days

Other adverse events

Other adverse events
Measure	Dexamethasone 20 mg n=52 participants at risk Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days Dexamethasone: Dexamethasone	Dexamethasone 6 mg n=55 participants at risk Dexamethasone 6 mg daily for 10 days Dexamethasone: Dexamethasone
Endocrine disorders hyperglycemia, requires insulin infusion	3.8% 2/52 • 28 days	1.8% 1/55 • 28 days
Infections and infestations bacteremia	5.8% 3/52 • 28 days	18.2% 10/55 • 28 days
Infections and infestations Catheter-related bloodstream infection	1.9% 1/52 • 28 days	5.5% 3/55 • 28 days
Infections and infestations Candidemia	0.00% 0/52 • 28 days	1.8% 1/55 • 28 days
Infections and infestations Pulmonary aspergillosis	0.00% 0/52 • 28 days	1.8% 1/55 • 28 days
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/52 • 28 days	1.8% 1/55 • 28 days

Additional Information

Manager of Clinical Trials

University of Oklahoma Health Sciences Center

Phone: 405-271-6173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place