Dexamethasone and COVID-19 Inpatient Mortality

Completed

• Conditions: Coronavirus
• Interventions: Drug: Dexamethasone Oral

• Registration Number: NCT04926571
• Lead Sponsor: Aetion, Inc.

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.

Detailed Description

This is a non-randomized, non-interventional study that is part of a research collaboration agreement between the US Food and Drug Administration (FDA) and Aetion to use real-world data to advance the understanding and the natural history of COVID-19 in specific patient populations, as well as treatment and diagnostic patterns during the coronavirus disease (COVID-19) pandemic.

This study compares inpatient mortality within 28 days among US patients hospitalized with COVID-19 diagnosis or SARS-CoV-2 infection who initiate dexamethasone treatment with a matched cohort of patients with 'standard of care' who are non-users of corticosteroids of interest (dexamethasone, prednisone, methylprednisolone, hydrocortisone). Patients are compared overall and and stratified by COVID-19 severity subgroups.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-15
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14105

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexamethasone versus methylprednisolone active comparator	Dexamethasone Oral	-
Dexamethasone versus non-users of corticosteroids	Dexamethasone Oral	-
Dexamethasone versus non-users of dexamethasone	Dexamethasone Oral	-

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	Mortality within 28 days of admission

Trial Locations

Locations (1)

Aetion, Inc.; 🇺🇸 New York, New York, United States