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
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|ClinicalTrials.gov Identifier: NCT04339634|
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2020
Last Update Posted : September 2, 2022
|Condition or disease||Intervention/treatment|
|COVID Drug Effect Drug Interaction Adverse Drug Event||Other: Simulation of Repurposed Drugs for COVID-19|
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;
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.
|Study Type :||Observational|
|Estimated Enrollment :||1600 participants|
|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|
|Actual Study Start Date :||April 2, 2020|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||October 1, 2023|
Program of All-Inclusive Care for the Elderly
The Program of All-Inclusive Care for the Elderly (PACE) provides comprehensive medical and supportive services for community-dwelling persons, mostly older adults (>55 years), as an alternative to institutionalization. Medical services are provided by an interdisciplinary team of healthcare professionals, Tabula Rasa HealthCare being the pharmacy care provider for several PACE organizations.
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.
Other Name: Simulation using proprietary risk stratification software
- To determine the Medication Risk Score of de-identified PACE's participants 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 5 factors computed by algorithms to derive the Medication Risk Score. [ Time Frame: 3 months ]Quantitative
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339634
|United States, Florida|
|Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute|
|Orlando, Florida, United States, 32827|
|Principal Investigator:||Veronique Michaud, PhD||Tabula Rasa HealthCare|