Dexamethasone and COVID-19 Inpatient Mortality

Aetion

Status: Completed

Conditions: Coronavirus

Treatments: Drug: Dexamethasone Oral

Study type: Observational

Funder types: Other

Identifiers

NCT04926571

RQ004-1-20210610

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14,105 patients

Sex: All

Volunteers: No 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 T)

Trial design

14,105 participants in 3 patient groups

Dexamethasone versus non-users of corticosteroids

Treatment:

Drug: Dexamethasone Oral

Dexamethasone versus non-users of dexamethasone

Treatment:

Drug: Dexamethasone Oral

Dexamethasone versus methylprednisolone active comparator

Treatment:

Drug: Dexamethasone Oral