Association of alpha-1 blocker (ɑ-1B) on coronavirus disease (COVID-19) susceptibility and severity

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40308
• EU PAS number:
  EUPAS36231
• Study ID:
  40308
• Official title and acronym:
  Association of alpha-1 blocker (ɑ-1B) on coronavirus disease (COVID-19) susceptibility and severity
• DARWIN EU® study:
  No
• Study countries:
  Spain

  United Kingdom

  United States
• Study description:
  This study will evaluate the effect of alpha-1 blocker (ɑ-1B) exposure on the risk of contracting COVID-19 infection and of subsequently requiring hospitalization and intensive services such as mechanical ventilation. The analysis will be undertaken across a federated multi-national network of electronic health records and administrative claims from primary care and secondary care that have been mapped to the Observational Medical Outcomes Partnership Common Data Model in collaboration with the Observational Health Data Sciences and Informatics (OHDSI) and European Health Data and Evidence Network (EHDEN) initiatives. These data reflect the clinical experience of patients from Spain, the United Kingdom, and the United States of America as data becomes available. We will use a prevalent user cohort design to estimate the relative risk of each outcome using an on-treatment analysis of monotherapy. Data driven approaches will be used to identify potential covariates for inclusion in matched or stratified propensity score models identified using regularized logistic regression. Large-scale propensity score matching and stratification strategies that allow balancing on a large number of baseline potential confounders will be used in addition to negative control outcomes to allow for evaluating residual bias in the study design as a whole as a diagnostic step.
• Study status:
  Finalised

Research institution and networks

Networks

Observational Health Data Sciences and Informatics (OHDSI) Network

European Health Data Evidence Network (EHDEN)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 07/07/2020

Actual: 07/07/2020

Study start date

Planned: 08/07/2020

Actual: 08/07/2020

Date of final study report

Planned: 30/10/2020

Actual: 24/03/2021

Sources of funding

Other

More details on funding

IMI EHDEN

Study protocol

Initial protocol

alpha_blocker_study_protocol (1)

Updated protocol

alpha_blocker_study_protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable