NCT04707534

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Jan 2021

Typical duration for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

March 29, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

January 11, 2021

Results QC Date

December 4, 2023

Last Update Submit

March 28, 2024

Conditions

Covid19

Keywords

COVID 19

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinical Improvement of Greater Than or Equal to 2 Points Using the WHO-OSCI at Day 28

    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

    28 days from study enrollment

Secondary Outcomes (1)

  • 28-day Mortality

    28 days from study enrollment

Study Arms (2)

Dexamethasone 20 mg

EXPERIMENTAL

Dexamethasone 20 mg daily for 5 days, followed by dexamethasone 10 mg daily for 5 days

Drug: Dexamethasone

Dexamethasone 6 mg

ACTIVE COMPARATOR

Dexamethasone 6 mg daily for 10 days

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Dexamethasone

Dexamethasone 20 mgDexamethasone 6 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Wu H, Daouk S, Kebbe J, Chaudry F, Harper J, Brown B. Low-dose versus high-dose dexamethasone for hospitalized patients with COVID-19 pneumonia: A randomized clinical trial. PLoS One. 2022 Oct 3;17(10):e0275217. doi: 10.1371/journal.pone.0275217. eCollection 2022.

    PMID: 36190994DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Manager of Clinical Trials
Organization
University of Oklahoma Health Sciences Center
Dianne-Belshe@ouhsc.edu
405-271-6173

Study Officials

  • Huimin Wu, MD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

January 21, 2021

Primary Completion

December 31, 2021

Study Completion

March 4, 2022

Last Updated

March 29, 2024

Results First Posted

March 29, 2024

Record last verified: 2024-03

Locations

US(1)