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

NCT ID: NCT04378881

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-12

Study Completion Date

2023-11-11

Brief Summary

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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

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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

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COVID Drug Effect Drug Interaction Adverse Drug Event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambia Health Solutions

INDUSTRY

Sponsor Role collaborator

Tabula Rasa HealthCare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronique Michaud

Role: PRINCIPAL_INVESTIGATOR

Tabula Rasa HealthCare

Locations

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Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.carekinesis.com/wp-content/uploads/2018_Cicali_B_Benefits_Q_Application_of_a_novel_medication-related_risk_stratification_strategy.pdf

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

Other Identifiers

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COVID19-TRHC-2020-002

Identifier Type: -

Identifier Source: org_study_id

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