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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04339634
• Other study ID #: COVID-PACE-2020-001
• Status: Completed
• Start date: April 2, 2020
• Est. completion date: January 30, 2023

Study information

• Verified date: January 2023
• Source: Tabula Rasa HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12873
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• COVID
• COVID-19
• Drug Effect
• Drug Interaction
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.

Locations

Country	Name	City	State
United States	Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tabula Rasa HealthCare

Country where clinical trial is conducted

United States, 

References & Publications (5)

Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese. — View Citation

Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr Pharmacother. 2007 Dec;5(4):345-51. doi: 10.1016/j.amjopharm.2007.12.002. — View Citation

Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available. — View Citation

Stabler T, Piette JC, Chevalier X, Marini-Portugal A, Kraus VB. Serum cytokine profiles in relapsing polychondritis suggest monocyte/macrophage activation. Arthritis Rheum. 2004 Nov;50(11):3663-7. doi: 10.1002/art.20613. — View Citation

Vouri SM, Crist SM, Sutcliffe S, Austin S. Changes in Mood in New Enrollees at a Program of All-Inclusive Care for the Elderly. Consult Pharm. 2015 Aug;30(8):463-71. doi: 10.4140/TCP.n.2015.463. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.	Quantitative	Three months
Primary	To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen.	Quantitative	Three months
Primary	To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19.	Quantitative	Three months
Primary	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.	Quantitative	3 months
Secondary	To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.	Qualitative	6 months
Secondary	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.	Qualitative	1 year

External Links

•   Application of a Novel Medication-Related Risk Stratification
•   World Health Organization: COVID-19