Clinical trial NCT04432350: Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications
Official title: Assessment of Mortality Rates in SARS-CoV-2 Infected Populations Treated With Repurposed Medications
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID
Drug Effect
Drug Interaction
Risk Reduction
Keywords: COVID-19
Adverse Drug Event
Mortality Rate
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined.
timeFrame: Six months
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.
timeFrame: Six months
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.
timeFrame: Six months
Secondary outcomes:
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.
timeFrame: 1 year
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.
timeFrame: 1 year
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.
timeFrame: 1 year
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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute
state: Florida
Study officials:
affiliation: Tabula Rasa HealthCare
name: Veronique Michaud
role: PRINCIPAL_INVESTIGATOR
References:
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.