Dexamethasone and COVID-19 Inpatient Mortality

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronavirus

Intervention / Treatment
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* Drug: Dexamethasone Oral


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexamethasone versus non-users of corticosteroids<br> | Drug: Dexamethasone Oral<br>* New users of Dexamethasone<br>|
| Dexamethasone versus non-users of dexamethasone<br> | Drug: Dexamethasone Oral<br>* New users of Dexamethasone<br>|
| Dexamethasone versus methylprednisolone active comparator<br> | Drug: Dexamethasone Oral<br>* New users of Dexamethasone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality within 28 days of admission | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment, dexamethasone, corticosteroid, mortality