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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04378881
• Other study ID #: COVID19-TRHC-2020-002
• Status: Enrolling by invitation
• Start date: June 12, 2020
• Est. completion date: November 11, 2023

Study information

• Verified date: September 2022
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: November 11, 2023
• Est. primary completion date: June 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• COVID
• COVID-19
• Drug Effect
• Drug Interaction
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
United States	Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare	Cambia Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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

External Links

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