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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 Frail Elderly Adults With Polypharmacy

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: NCT04339634
Recruitment Status : Active, not recruiting
First Posted : April 9, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Tabula Rasa HealthCare

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 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.

Condition or disease Intervention/treatment
COVID Drug Effect Drug Interaction Adverse Drug Event Other: Simulation of Repurposed Drugs for 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.

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Study Type : Observational
Actual Enrollment : 12123 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 7, 2020
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : April 6, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
Orlando, Florida, United States, 32827
Sponsors and Collaborators
Tabula Rasa HealthCare
Investigators
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Principal Investigator: Veronique Michaud, PhD Tabula Rasa HealthCare
Additional Information:
Publications:
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Responsible Party: Tabula Rasa HealthCare
ClinicalTrials.gov Identifier: NCT04339634    
Other Study ID Numbers: COVID-PACE-2020-001
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tabula Rasa HealthCare:
COVID-19
Elderly
Adverse Drug Event
Repurposed Drug
Drug Interaction
LQTS
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders