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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12,873 (actual)
• Sponsor: Tabula Rasa HealthCare · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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 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.

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 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: 1. Patient enrolled in a PACE organization during the implementation period; 2. 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.

Conditions

• COVID
• Drug Effect
• Drug Interaction
• Adverse Drug Event

Interventions

Type	Name	Description
OTHER	Simulation of Repurposed Drugs for COVID-19	This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.

Timeline

• Start date: 2020-04-02
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2020-04-09
• Last updated: 2023-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study