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OpenTrials
Completed

NCT Number: NCT04707534

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104, United States

About this study

The coronavirus disease 2019 (COVID-19) pandemic is a serious global health threat. Multiple antiviral or immunomodulatory therapies have failed to show any mortality benefit for patients with COVID-19. Dexamethasone was shown in prior studies to improve mortality and ventilator free days. However, it is unclear what dose of dexamethasone is most beneficial in hospitalized patients with COVID-19. This randomized single center open label clinical trial is to evaluate two different doses of dexamethasone (20mg vs. 6mg) on the health outcome for hospitalized patients with COVID-19. The intervention arm is dexamethasone 20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. The comparator is dexamethasone 6mg daily for 10 days. Three hundred participants will be enrolled. The primary outcome is clinical improvement using World Health Organization ordinal scale at day 28.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. 28-day Mortality

    Time frame: 28 days from study enrollment

    All-cause mortality at 28 days after enrollment

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2021
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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