NCT04707534

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

Completed Phase 4 Results posted Last updated 29 March 2024

What this trial tests

Phase 4 trial testing Dexamethasone in Covid19 in 110 participants. Completed in 4 March 2022.

Timeline

21 January 2021

Primary endpoint
31 December 2021

4 March 2022

Quick facts

Lead sponsor	University of Oklahoma
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	21 January 2021
Primary completion	31 December 2021
Estimated completion	4 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

University of Oklahoma

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28 Primary · 28 days from study enrollment

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

Group	Value	95% CI
Dexamethasone 20 mg	37
Dexamethasone 6 mg	43

28-day Mortality Secondary · 28 days from study enrollment

All-cause mortality at 28 days after enrollment

Group	Value	95% CI
Dexamethasone 20 mg	11
Dexamethasone 6 mg	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexamethasone 20 mg

Serious: 1/52 (2%)

Deaths: 11/52

Dexamethasone 6 mg

Serious: 2/55 (4%)

Deaths: 5/55

Serious adverse events (1 terms)

Reaction	System	Dexamethasone 20 mg	Dexamethasone 6 mg
Ventilator associated pneumonia	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Dexamethasone 20 mg	Dexamethasone 6 mg
bacteremia	Infections and infestations	—	—
Catheter-related bloodstream infection	Infections and infestations	—	—
hyperglycemia, requires insulin infusion	Endocrine disorders	—	—
Candidemia	Infections and infestations	—	—
Pulmonary aspergillosis	Infections and infestations	—	—
Gastrointestinal bleeding	Gastrointestinal disorders	—	—

Most-reported serious reactions: Ventilator associated pneumonia.

Data from ClinicalTrials.gov NCT04707534 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systemic corticosteroids for the treatment of COVID-19.
   Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
2. Molecular mechanisms and therapeutic target of NETosis in diseases.
   Huang J, Hong W, Wan M, Zheng L. · · 2022 · cited 145× · PMID 36000086 · DOI 10.1002/mco2.162
3. Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
   Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2
4. Low-dose versus high-dose dexamethasone for hospitalized patients with COVID-19 pneumonia: A randomized clinical trial.
   Wu H, Daouk S, Kebbe J, Chaudry F, et al · · 2022 · cited 23× · PMID 36190994 · DOI 10.1371/journal.pone.0275217
5. Corticosteroids: A boon or bane for COVID-19 patients?
   Sen S, Singh B, Biswas G. · · 2022 · cited 8× · PMID 36029810 · DOI 10.1016/j.steroids.2022.109102
6. A close-up view of dynamic biomarkers in the setting of COVID-19: Striking focus on cardiovascular system.
   Rezabakhsh A, Sadat-Ebrahimi SR, Ala A, Nabavi SM, et al · · 2022 · cited 7× · PMID 34894069 · DOI 10.1111/jcmm.17122
7. A patient-tailored approach for corticosteroid treatment in COVID-19: still not there yet.
   Nigro M, Chalmers JD, Aliberti S. · · 2023 · cited 4× · PMID 36858444 · DOI 10.1183/13993003.00270-2023
8. Inhibition of coronavirus HCoV-OC43 by targeting the eIF4F complex.
   Feng Y, Grotegut S, Jovanovic P, Gandin V, et al · · 2022 · cited 4× · PMID 36532738 · DOI 10.3389/fphar.2022.1029093