NCT04926571

Dexamethasone and COVID-19 Inpatient Mortality

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14,105 (actual)
• Sponsor: Aetion, Inc. · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus

Interventions

Type	Name	Description
DRUG	Dexamethasone Oral	New users of Dexamethasone

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2021-06-15
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study