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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

Sponsor
Tabula Rasa HealthCare (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04378881
Collaborator
Cambia Health Solutions (Other)
100
Enrollment
1
Location
41
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jun 12, 2020
    Anticipated Primary Completion Date :
    Jun 11, 2023
    Anticipated Study Completion Date :
    Nov 11, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Three months]

      Quantitative

    2. 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. [Three months]

      Quantitative

    3. 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. [Three months]

      Quantitative

    4. 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. [Three months]

      Quantitative

    Secondary Outcome Measures

    1. 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. [Six months]

      Qualitative

    2. 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. [One year]

      Qualitative

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute Orlando Florida United States 32827

    Sponsors and Collaborators

    • Tabula Rasa HealthCare
    • Cambia Health Solutions

    Investigators

    • Principal Investigator: Veronique Michaud, Tabula Rasa HealthCare

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Tabula Rasa HealthCare
    ClinicalTrials.gov Identifier:
    NCT04378881
    Other Study ID Numbers:
    • COVID19-TRHC-2020-002
    First Posted:
    May 7, 2020
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tabula Rasa HealthCare
    COVID-19
    Repurposed Drug
    Drug Interaction
    LQTS
    Additional relevant MeSH terms:
    COVID-19
    Drug-Related Side Effects and Adverse Reactions

    Study Results

    No Results Posted as of Mar 3, 2022