Dexamethasone and COVID-19 Inpatient Mortality

NCT04926571 | Completed FDA Drug

• 1 other identifier: RQ004-1-20210610
• Study Type: observational
• Target: 14,105
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the effectiveness of dexamethasone initiation to reduce the risk of inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection, overall and stratified by COVID-19 severity subgroups.

Conditions

Coronavirus

Keywords

treatment; dexamethasone; corticosteroid; mortality

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality within 28 days of admission

  28 days

Study Arms (3)

Dexamethasone versus non-users of corticosteroids

Drug: Dexamethasone Oral

Dexamethasone versus non-users of dexamethasone

Drug: Dexamethasone Oral

Dexamethasone versus methylprednisolone active comparator

Drug: Dexamethasone Oral

Interventions

Dexamethasone Oral DRUG

New users of Dexamethasone

Dexamethasone versus methylprednisolone active comparator; Dexamethasone versus non-users of corticosteroids; Dexamethasone versus non-users of dexamethasone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date. Patients will enter the cohort upon the admission date of the first qualifying inpatient hospitalization observed in the hospital chargemaster data. The first eligible cohort entry date is 01-April-2020, the date when the ICD-10 code for COVID-19 diagnosis was added.

You may qualify if:

• Hospitalized Patients with confirmed COVID-19 (diagnosis of U07.1 or positive or presumptive positive SARS-CoV-2 diagnostic laboratory test result) occurring between 21 days prior to the hospital admission date and the treatment index date.

You may not qualify if:

• No interaction with the healthcare system (medical encounter) in the 183 days prior to and including hospital admission (Day -183 to Day 0) to minimize the potential for misclassification of baseline covariates and/or new use
• No age or sex recorded in the 183 days prior to and including hospital admission (Day -183 to Day 0) as required for matching
• No geographic region recorded in 183 days prior to and including hospital admission (Day -183 to Day 0) as necessary to adjust for regional variation
• Any recorded use of any CSI (dispensing or remaining supply) in the 90-day washout prior to the treatment index date (Day T-90 to Day T-1) to satisfy new use definition
• Any record of a COVID-19 vaccine recorded on or any time prior to the treatment index date given that these patients are assumed to be selectively different (Day S to Day T)

Sponsors & Collaborators

• Aetion, Inc.: lead

Study Sites (1)

Aetion, Inc.

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 15, 2021
• Study Start: April 1, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)