Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 6:38 AM
Study NCT ID:
NCT04339634
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2020-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12873}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To determine the Medication Risk Score of de-identified PACE's participants using their current drug regimen.", 'timeFrame': 'Three months', 'description': 'Quantitative'}, {'measure': 'To simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen.', 'timeFrame': 'Three months', 'description': 'Quantitative'}, {'measure': 'To compare the impact on Medication Risk Score before and after the addition of repurposed drugs for COVID-19.', 'timeFrame': 'Three months', 'description': 'Quantitative'}, {'measure': '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.', 'timeFrame': '3 months', 'description': 'Quantitative'}], 'secondaryOutcomes': [{'measure': 'To investigate the effects of various covariables on the Medication Risk Score in the presence of repurposed drugs for COVID-19.', 'timeFrame': '6 months', 'description': 'Qualitative'}, {'measure': '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.', 'timeFrame': '1 year', 'description': 'Qualitative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Elderly', 'Adverse Drug Event', 'Repurposed Drug', 'Drug Interaction', 'LQTS'], 'conditions': ['COVID', 'Drug Effect', 'Drug Interaction', 'Adverse Drug Event']}, 'referencesModule': {'references': [{'pmid': '32064853', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18179993', 'type': 'BACKGROUND', '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.'}, {'pmid': '32192578', 'type': 'BACKGROUND', '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.'}, {'pmid': '15529362', 'type': 'BACKGROUND', '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.'}, {'pmid': '26260643', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019', 'label': 'World Health Organization: COVID-19'}, {'url': 'http://www.carekinesis.com/wp-content/uploads/2018_Cicali_B_Benefits_Q_Application_of_a_novel_medication-related_risk_stratification_strategy.pdf', 'label': 'Application of a Novel Medication-Related Risk Stratification'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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.\n\nPatients meeting all the following criteria will be included:\n\n1. Patient enrolled in a PACE organization during the implementation period;\n2. PACE organization contractually receiving pharmacy services from CareKinesis;\n\nExclusion Criteria\n\na) No drug claims data available for the period of 2019-2020\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient enrolled in a PACE organization during the implementation period;\n* PACE organization contractually receiving pharmacy services from CareKinesis;\n\nExclusion Criteria:\n\n* No drug claims data available for the period of 2019-2020'}, 'identificationModule': {'nctId': 'NCT04339634', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tabula Rasa HealthCare'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'COVID-PACE-2020-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Program of All-Inclusive Care for the Elderly', 'description': '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.', 'interventionNames': ['Other: Simulation of Repurposed Drugs for COVID-19']}], 'interventions': [{'name': 'Simulation of Repurposed Drugs for COVID-19', 'type': 'OTHER', 'otherNames': ['Simulation using proprietary risk stratification software'], 'description': 'This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.', 'armGroupLabels': ['Program of All-Inclusive Care for the Elderly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Veronique Michaud, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabula Rasa HealthCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabula Rasa HealthCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}