<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432350</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19_TRHCPrescribeWellness</org_study_id>
    <nct_id>NCT04432350</nct_id>
  </id_info>
  <brief_title>Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications</brief_title>
  <official_title>Assessment of Mortality Rates in SARS-CoV-2 Infected Populations Treated With Repurposed Medications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tabula Rasa HealthCare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tabula Rasa HealthCare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective cohort study will include eligible patients that received a positive&#xD;
      COVID-19 test and filled a new prescription for one of the repurposed medications (including&#xD;
      hydroxychloroquine, chloroquine, with or without azithromycin) for the treatment of COVID-19&#xD;
      at a PrescribeWellness pharmacy. The study will use de-identified data collected from&#xD;
      February 1, 2020 to start of study. The data set will include: repurposed medication name,&#xD;
      strength, and dose; age (age limit set at 89 years old); gender; provider type; zip code&#xD;
      (excludes 17 three-digit zip code tabulation areas that have a population of 20,000 or fewer&#xD;
      persons); conditions; mortality; and a list of concomitant prescriptions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a deficit in literature assessing the risk associated with these repurposed&#xD;
      medications in COVID-19 patients. The investigators propose to evaluate if the use of&#xD;
      repurposed drugs including hydroxychloroquine and chloroquine is associated with an increased&#xD;
      risk of mortality in COVID-19 infected patients treated with such medications.&#xD;
&#xD;
      PrescribeWellness, a Tabula Rasa HealthCare solution, a leading patient relationship&#xD;
      management service provider in U.S., facilitates collaboration between more than 15,000&#xD;
      pharmacies and payers, providers, and patients for better health. PrescribeWellness empowers&#xD;
      community pharmacies with innovative technological solutions that advance a pharmacist's&#xD;
      ability to identify, manage, and drive patient care interventions. On average, 2,000 patients&#xD;
      receive their services per each pharmacy. PrescribeWellness expands the medication risk&#xD;
      mitigation program of Tabula Rasa HealthCare in community pharmacies and ambulatory patients.&#xD;
      The investigators propose to perform a retrospective analysis of data from infected COVID-19&#xD;
      patients served by PrescribeWellness pharmacies for assessing mortality and risk/benefit&#xD;
      associated with the use of repurposed COVID-19 drugs.&#xD;
&#xD;
      An approach to reduce and predict adverse drug events is the use of predictive risk scores.&#xD;
      Tabula Rasa HealthCare's proprietary MedWise Risk Score™ (MRS) is based on five aggregated&#xD;
      medication risk mitigation factors: FAERS (FDA adverse events reporting system) risk score,&#xD;
      anticholinergic burden, sedative burden, drug-induced long QT syndrome, and CYP450 drug&#xD;
      interaction burden. The MRS™ is a predictive tool used by health care providers to determine&#xD;
      which factors, including prescription drugs, can contribute the most to a patient's&#xD;
      likelihood of an adverse drug event (ADE) occurring. In order to calculate the MRS™, patient&#xD;
      data is first de-identified, and then comprised by various physiological, pharmacological and&#xD;
      biochemical variables. Once a patient is analyzed, his/her MRS™ is defined as Very Low, Low,&#xD;
      Moderate, High, or Very High Risk for the likelihood of ADE. The investigators propose to&#xD;
      retrospectively calculate the MRSTM and assess the predictive value of MRS™ in patients&#xD;
      tested positive for COVID-19 and who were treated with repurposed drugs. The investigators&#xD;
      hypothesize that an increase rate of mortality is associated with high risk MRS in patients&#xD;
      receiving repurposed drugs against COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Limitations with data.&#xD;
  </why_stopped>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">May 26, 2022</completion_date>
  <primary_completion_date type="Actual">May 26, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined.</measure>
    <time_frame>Six months</time_frame>
    <description>Quantitative</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Six months</time_frame>
    <description>Quantitative</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>Six months</time_frame>
    <description>Quantitative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>Quantitative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>Quantitative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>Quantitative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1 year</time_frame>
    <description>Quantitative</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>Drug Effect</condition>
  <condition>Drug Interaction</condition>
  <condition>Risk Reduction</condition>
  <arm_group>
    <arm_group_label>Treated with Repurposed Drugs</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not Treated with Repurposed Drugs</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        PrescribeWellness is a national pharmacy network that serves over 15,000 pharmacies, with&#xD;
        an average of over 2,000 patients per pharmacy (~30 million patients). Data will be&#xD;
        provided by Tabula Rasa HealthCare PrescribeWellness Analytics department to Tabula Rasa&#xD;
        HealthCare's Precision Pharmacotherapy Research &amp; Development Institute. All protected&#xD;
        health information (PHI) will be removed from the data set before its transfer through an&#xD;
        encrypted server.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving services at a PrescribeWellness pharmacy;&#xD;
&#xD;
          -  Patients who received a COVID-19 positive test at a PrescribeWellness Pharmacy or&#xD;
             other certified COVID-19 test centers since February 1, 2020;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who received a COVID-19 negative test at a PrescribeWellness Pharmacy or&#xD;
             other certified COVID-19 test centers since February 1, 2020;&#xD;
&#xD;
          -  Patients who received COVID-19 repurposed drugs without laboratory-confirmed test for&#xD;
             COVID-19 disease;&#xD;
&#xD;
          -  Patients who were receiving COVID-19 repurposed drugs prior to February 1, 2020.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veronique Michaud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tabula Rasa HealthCare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.who.int/emergencies/diseases/novel-coronavirus-2019</url>
    <description>COVID-19 Dashboard</description>
  </link>
  <link>
    <url>http://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020</url>
    <description>WHO COVID-19 Statement</description>
  </link>
  <link>
    <url>http://coronavirus.jhu.edu/map.html</url>
    <description>Coronavirus Dashboard Johns Hopkins</description>
  </link>
  <reference>
    <citation>Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10.</citation>
    <PMID>32283155</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Adverse Drug Event</keyword>
  <keyword>Mortality Rate</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432350
org study id: COVID-19_TRHCPrescribeWellness
nct id: NCT04432350
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined.
time frame: Six months
description: Quantitative
measure: 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.
time frame: Six months
description: Quantitative
measure: 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.
time frame: Six months
description: Quantitative
measure: 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.
time frame: 1 year
description: Quantitative
measure: 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.
time frame: 1 year
description: Quantitative
measure: 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.
time frame: 1 year
description: Quantitative
measure: 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.
time frame: 1 year
description: Quantitative
arm group label: Treated with Repurposed Drugs
description: 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.
arm group label: Not Treated with Repurposed Drugs
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Veronique Michaud
role: Principal Investigator
affiliation: Tabula Rasa HealthCare
facility: 
country: United States
url: http://www.who.int/emergencies/diseases/novel-coronavirus-2019
description: COVID-19 Dashboard
url: http://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020
description: WHO COVID-19 Statement
url: http://coronavirus.jhu.edu/map.html
description: Coronavirus Dashboard Johns Hopkins
citation: Fu L, Wang B, Yuan T, Chen X, Ao Y, Fitzpatrick T, Li P, Zhou Y, Lin YF, Duan Q, Luo G, Fan S, Lu Y, Feng A, Zhan Y, Liang B, Cai W, Zhang L, Du X, Li L, Shu Y, Zou H. Clinical characteristics of coronavirus disease 2019 (COVID-19) in China: A systematic review and meta-analysis. J Infect. 2020 Jun;80(6):656-665. doi: 10.1016/j.jinf.2020.03.041. Epub 2020 Apr 10.
PMID: 32283155
responsible party type: Sponsor
sharing ipd: No