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

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.

Withdrawn
COVID
Drug Effect
Drug Interaction
Risk Reduction
Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Countries
United States
Locations

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

Veronique Michaud, Principal Investigator
Tabula Rasa HealthCare

Tabula Rasa HealthCare
NCT Number
Keywords
Covid-19
Adverse Drug Event
Mortality Rate