Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications

Sponsor
Tabula Rasa HealthCare (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04432350
Collaborator
(none)
0
1
23.4
0

Study Details

Study Description

Brief Summary

This retrospective cohort study will include eligible patients that received a positive COVID-19 test and filled a new prescription for one of the repurposed medications (including hydroxychloroquine, chloroquine, with or without azithromycin) for the treatment of COVID-19 at a PrescribeWellness pharmacy. The study will use de-identified data collected from February 1, 2020 to start of study. The data set will include: repurposed medication name, strength, and dose; age (age limit set at 89 years old); gender; provider type; zip code (excludes 17 three-digit zip code tabulation areas that have a population of 20,000 or fewer persons); conditions; mortality; and a list of concomitant prescriptions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    There is a deficit in literature assessing the risk associated with these repurposed medications in COVID-19 patients. The investigators propose to evaluate if the use of repurposed drugs including hydroxychloroquine and chloroquine is associated with an increased risk of mortality in COVID-19 infected patients treated with such medications.

    PrescribeWellness, a Tabula Rasa HealthCare solution, a leading patient relationship management service provider in U.S., facilitates collaboration between more than 15,000 pharmacies and payers, providers, and patients for better health. PrescribeWellness empowers community pharmacies with innovative technological solutions that advance a pharmacist's ability to identify, manage, and drive patient care interventions. On average, 2,000 patients receive their services per each pharmacy. PrescribeWellness expands the medication risk mitigation program of Tabula Rasa HealthCare in community pharmacies and ambulatory patients. The investigators propose to perform a retrospective analysis of data from infected COVID-19 patients served by PrescribeWellness pharmacies for assessing mortality and risk/benefit associated with the use of repurposed COVID-19 drugs.

    An approach to reduce and predict adverse drug events is the use of predictive risk scores. Tabula Rasa HealthCare's proprietary MedWise Risk Score™ (MRS) is based on five aggregated medication risk mitigation factors: FAERS (FDA adverse events reporting system) risk score, anticholinergic burden, sedative burden, drug-induced long QT syndrome, and CYP450 drug interaction burden. The MRS™ is a predictive tool used by health care providers to determine which factors, including prescription drugs, can contribute the most to a patient's likelihood of an adverse drug event (ADE) occurring. In order to calculate the MRS™, patient data is first de-identified, and then comprised by various physiological, pharmacological and biochemical variables. Once a patient is analyzed, his/her MRS™ is defined as Very Low, Low, Moderate, High, or Very High Risk for the likelihood of ADE. The investigators propose to retrospectively calculate the MRSTM and assess the predictive value of MRS™ in patients tested positive for COVID-19 and who were treated with repurposed drugs. The investigators hypothesize that an increase rate of mortality is associated with high risk MRS in patients receiving repurposed drugs against COVID-19.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of Mortality Rates in SARS-CoV-2 Infected Populations Treated With Repurposed Medications
    Actual Study Start Date :
    Jun 12, 2020
    Actual Primary Completion Date :
    May 26, 2022
    Actual Study Completion Date :
    May 26, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Treated with Repurposed Drugs

    This cohort will be for individuals who have tested positive for COVID-19 and were treated with repurposed drugs. This will be tracked via drug claims data in a PrescribeWellness Pharmacy.

    Not Treated with Repurposed Drugs

    This cohort will be for individuals who have tested positive for COVID-19 and were not treated with repurposed drugs. This will be tracked via drug claims data in a PrescribeWellness Pharmacy.

    Outcome Measures

    Primary Outcome Measures

    1. The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined. [Six months]

      Quantitative

    2. The relationship between high-risk cardio-pulmonary and vascular comorbidities (e.g., hypertension, dyslipidemia, diabetes, and chronic lung diseases) and mortality with use of repurposed medications for the treatment of COVID-19 will be investigated. [Six months]

      Quantitative

    3. The MRS™ will be calculated using drug claim data from confirmed COVID-19 patients and explore the predictive value of MRS™ for ADE, LQTS and all-cause of death. [Six months]

      Quantitative

    Secondary Outcome Measures

    1. To compare the rates of death in COVID-19 confirmed patients treated with repurposed medications versus COVID-19 confirmed patients not treated with repurposed drugs. [1 year]

      Quantitative

    2. The relationship between medications used to treat these underlying health conditions (e.g. ACE inhibitors, angiotensin type 1 receptor blockers, aliskiren, and mineralocorticoid antagonists) and mortality in patients with a confirmed COVID-19 infection. [1 year]

      Quantitative

    3. To compare the MRS™ and its predictive value for ADE between confirmed COVID-19 patients treated with repurposed drugs and confirmed patients not treated with repurposed drugs. [1 year]

      Quantitative

    4. To examine drug regimen patterns associated with higher risk of MRS™, ADEs, and higher rates of death in confirmed COVID-19 patients with and without repurposed medication. [1 year]

      Quantitative

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients receiving services at a PrescribeWellness pharmacy;

    • Patients who received a COVID-19 positive test at a PrescribeWellness Pharmacy or other certified COVID-19 test centers since February 1, 2020;

    Exclusion Criteria:
    • Patients who received a COVID-19 negative test at a PrescribeWellness Pharmacy or other certified COVID-19 test centers since February 1, 2020;

    • Patients who received COVID-19 repurposed drugs without laboratory-confirmed test for COVID-19 disease;

    • Patients who were receiving COVID-19 repurposed drugs prior to February 1, 2020.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute Orlando Florida United States 32827

    Sponsors and Collaborators

    • Tabula Rasa HealthCare

    Investigators

    • Principal Investigator: Veronique Michaud, Tabula Rasa HealthCare

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Tabula Rasa HealthCare
    ClinicalTrials.gov Identifier:
    NCT04432350
    Other Study ID Numbers:
    • COVID-19_TRHCPrescribeWellness
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tabula Rasa HealthCare

    Study Results

    No Results Posted as of Jun 16, 2022