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

Assessment of Mortality Rates in SARS-CoV-2 Infected Populations Treated With Repurposed Medications

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID; Drug Effect; Risk Reduction; Drug Interaction

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PrescribeWellness is a national pharmacy network that serves over 15,000 pharmacies, with an average of over 2,000 patients per pharmacy (~30 million patients). Data will be provided by Tabula Rasa HealthCare PrescribeWellness Analytics department to Tabula Rasa HealthCare's Precision Pharmacotherapy Research & Development Institute. All protected health information (PHI) will be removed from the data set before its transfer through an encrypted server.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined.	Quantitative	Six months
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.	Quantitative	Six months
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.	Quantitative	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Quantitative	1 year
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.	Quantitative	1 year
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.	Quantitative	1 year
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.	Quantitative	1 year

Collaborators and Investigators

• Sponsor: Tabula Rasa HealthCare

Publications and helpful links

General Publications

• 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.

Helpful Links

• COVID-19 Dashboard
• WHO COVID-19 Statement
• Coronavirus Dashboard Johns Hopkins

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2020
• Primary Completion (ACTUAL): May 26, 2022
• Study Completion (ACTUAL): May 26, 2022

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Adverse Drug Event; Mortality Rate
• Other Study ID Numbers: COVID-19_TRHCPrescribeWellness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No