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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04378881
Recruitment Status : Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Cambia Health Solutions
Information provided by (Responsible Party):
Tabula Rasa HealthCare

Tracking Information
First Submitted Date May 5, 2020
First Posted Date May 7, 2020
Last Update Posted Date June 30, 2020
Actual Study Start Date June 1, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
  • 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. [ Time Frame: Three months ]
    Quantitative
  • 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. [ Time Frame: Three months ]
    Quantitative
  • 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. [ Time Frame: Three months ]
    Quantitative
  • 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. [ Time Frame: Three months ]
    Quantitative
Original Primary Outcome Measures
 (submitted: May 5, 2020)
  • To determine the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen. [ Time Frame: Three months ]
    Quantitative
  • To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen. [ Time Frame: Three months ]
    Quantitative
  • To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19. [ Time Frame: Three months ]
    Quantitative
  • To assess and compare the effects of various repurposed drugs for COVID-19 on each of the five factors computed by algorithms to derive the Medication Risk Score. [ Time Frame: Three months ]
    Quantitative
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2020)
  • 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. [ Time Frame: Six months ]
    Qualitative
  • 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. [ Time Frame: One year ]
    Qualitative
Original Secondary Outcome Measures
 (submitted: May 5, 2020)
  • To compare 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. [ Time Frame: Six months ]
    Qualitative
  • To explore 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. [ Time Frame: One year ]
    Qualitative
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID
  • Drug Effect
  • Drug Interaction
  • Adverse Drug Event
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 5, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04378881
Other Study ID Numbers COVID19-TRHC-2020-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Tabula Rasa HealthCare
Study Sponsor Tabula Rasa HealthCare
Collaborators Cambia Health Solutions
Investigators
Principal Investigator: Veronique Michaud Tabula Rasa HealthCare
PRS Account Tabula Rasa HealthCare
Verification Date June 2020