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Completed

NCT Number: NCT04339634

Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Frail Elderly Adults With Polypharmacy

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 elderly people enrolled in PACE organizations. Our clinical tool would enable to identify potential multi-drug interactions and potentially reduce the risk of adverse drug events (ADE) developing in elderly patients infected with COVID-19.

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Key information

Conditions

COVID Adverse Drug Event COVID-19 Chemically-Induced Disorders Coronaviridae Infections Coronavirus Infections Drug Effect Drug Interaction Drug-Related Side Effects and Adverse Reactions Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, 32827, United States

About this study

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 on 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 of elderly patients with polypharmacy.

Patients meeting all the following criteria will be included:

  • Patient enrolled in a PACE organization during the implementation period;
  • PACE organization contractually receiving pharmacy services from CareKinesis;

Exclusion criteria

a) No drug claims data available for the period of 2019-2020

This retrospective cohort will utilize 178,867 drug claims from approximately 12,123 patients enrolled in PACE. MRS will be calculated using the last available 3-month period of drug claims in 2019. The data elements required for the calculation of the full set of risk scores are: prescribed drugs, dose, age, gender. Medication risk stratification using 5 factors will be performed to obtain the MRS. Various repurposed drugs (drugs associated with the highest probability or efficacy or shown interest as per their inclusion in current clinical trials will be prioritized) will be added to the patient drug regimen except for the patients that are currently taking the repurposed drug. A new MRS will be generated for all stratified patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient enrolled in a PACE organization during the implementation period;
  • PACE organization contractually receiving pharmacy services from CareKinesis;

Exclusion criteria

  • No drug claims data available for the period of 2019-2020

Treatment and study plan

Simulation of Repurposed Drugs for COVID-19

Other

This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.

Other names: Simulation using proprietary risk stratification software

Primary outcomes

  1. To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.

    Time frame: Three months

    Quantitative

  2. 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

  3. To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19.

    Time frame: Three months

    Quantitative

  4. To assess and compare the effects of various repurposed drugs for COVID-19 on each of the 5 factors computed by algorithms to derive the Medication Risk Score.

    Time frame: 3 months

    Quantitative

Secondary outcomes

  1. To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.

    Time frame: 6 months

    Qualitative

  2. 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.

    Time frame: 1 year

    Qualitative

Sponsors and collaborators

Lead sponsor

Tabula Rasa HealthCare

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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