Dexamethasone and COVID-19 Inpatient Mortality

Sponsor

Aetion, Inc. (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04926571

Collaborator

(none)

20,000

Enrollment

Location

26.9

Anticipated Duration (Months)

742.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus	Drug: Dexamethasone Oral

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 Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Dexamethasone versus non-users of corticosteroids	Drug: Dexamethasone Oral New users of Dexamethasone
Dexamethasone versus non-users of dexamethasone	Drug: Dexamethasone Oral New users of Dexamethasone
Dexamethasone versus methylprednisolone active comparator	Drug: Dexamethasone Oral New users of Dexamethasone

Arm

Intervention/Treatment

Dexamethasone versus non-users of corticosteroids

Drug: Dexamethasone Oral

New users of Dexamethasone

Dexamethasone versus non-users of dexamethasone

Drug: Dexamethasone Oral

New users of Dexamethasone

Dexamethasone versus methylprednisolone active comparator

Drug: Dexamethasone Oral

New users of Dexamethasone

Outcome Measures

Primary Outcome Measures

Mortality [28 days]
Mortality within 28 days of admission

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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