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

NCT04378881 | Unknown

• 1 other identifier: COVID19-TRHC-2020-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Drug Effect; Drug Interaction; Adverse Drug Event

Keywords

COVID-19; Repurposed Drug; Drug Interaction; LQTS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead
• Cambia Health Solutions: collaborator

Study Sites (1)

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, 32827, United States

Location

Related Links

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

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; COVID-19

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Veronique Michaud

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: June 12, 2020
• Primary Completion: June 11, 2023
• Study Completion: November 11, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)