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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID; Drug Effect; Adverse Drug Event; Drug Interaction

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The number of patients will change. 95,717 patients with Medicare/Medicaid health plan and 528,436 from commercial population.

Description

Inclusion Criteria:

• Patients enrolled with Cambia Health Solutions; Medicare/Medicaid or Commercial Health Insurance Plan
• Patients with drug claims available from 10/01/2018 to 10/31/2019

Exclusion Criteria:

• Patients with no drug claims available for 2018
• Health Plan for injectable drugs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculate the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen via our proprietary risk stratification process.	Quantitative	Three months
Simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen via our proprietary risk stratification process.	Quantitative	Three months
Compare the impact (change) on the Medication Risk Score using the calculate before score and simulated after score following the addition of repurposed drugs for COVID-19 to the drug regimens of patients enrolled in the study.	Quantitative	Three months
Measure the effects of various repurposed drugs for COVID-19 on each of the five factors computed by algorithms to derive the Medication Risk Score will be calculated via our proprietary risk stratification process.	Quantitative	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Medication Risk Score and the effects of the addition of repurposed drugs on the drug regimen between participants with Medicare/Medicaid vs. commercial health insurance plans will be assessed.	Qualitative	Six months
Measure the effects on Medication Risk Score of various repurposed drugs for COVID-19 within subgroups of patients classified by specific diseases or drugs used and the impact of various covariables.	Qualitative	One year

Collaborators and Investigators

• Sponsor: Tabula Rasa HealthCare
• Collaborators: Cambia Health Solutions

Publications and helpful links

Helpful Links

• Application of a Novel Medication-Related Risk Stratification Strategy to a Self-Funded Employer Population.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Anticipated): June 11, 2023
• Study Completion (Anticipated): November 11, 2023

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Drug Interaction; LQTS; Repurposed Drug
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: COVID19-TRHC-2020-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No