Dexamethasone and COVID-19 Inpatient Mortality

Coronavirus Clinical Trial

Official title:

Effect of Dexamethasone on Inpatient Mortality Among Hospitalized COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926571
• Other study ID #: RQ004-1-20210610
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: August 27, 2021

Study information

• Verified date: April 2023
• Source: Aetion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14105
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections

Intervention

Drug:
• Dexamethasone Oral
New users of Dexamethasone

Locations

Country	Name	City	State
United States	Aetion, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aetion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality within 28 days of admission	28 days