NCT04378881

Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Tabula Rasa HealthCare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This retrospective study aims to perform a medication risk stratification using drug claims data and to simulate the impact of the addition of various repurposed drugs on the Medication Risk Score (MRS) in a health insurance population. Our clinical tool would enable us to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in these patients infected with COVID-19.

Detailed description

Certain investigational agents have been described in observational series or are being used anecdotally based on in vitro or extrapolated evidence. It is important to acknowledge that there are no controlled data supporting the use of any of these agents, and their efficacy for COVID-19 is unknown. FDA-approved drugs such as chloroquine/hydroxychloroquine, lopinavir/ritonavir, monoclonal IL-6 antibodies, JAK inhibitors, thalidomide, and the new investigational drug remdesivir, have been proposed for repurposing to fight COVID-19 and its complications. A medication risk stratification strategy will be used to simulate the impacts of different potential repurposed drugs for COVID-19 and the Medication Risk Score (MRS) which is used as a predictive tool for ADEs. A retrospective study will be conducted using de-identified drug claims data for commercially insured patients.

Conditions

• COVID
• Drug Effect
• Drug Interaction
• Adverse Drug Event

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-06-11
• Completion: 2023-11-11
• First posted: 2020-05-07
• Last updated: 2022-09-02

Locations

1 site across 1 country: United States