Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04432350
Study type Observational
Source Tabula Rasa HealthCare
Contact
Status Withdrawn
Phase
Start date June 12, 2020
Completion date May 26, 2022

See also
  Status Clinical Trial Phase
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Active, not recruiting NCT04420676 - Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04395911 - Safety and Efficacy of SCD in AKI or ARDS Patients Associated With COVID-19 Infections N/A
Completed NCT04425317 - Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients N/A
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Withdrawn NCT04456426 - Characteristics of Patients With COVID-19 in Meta State, Colombia
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04425720 - Use of Remote Monitoring for COVID-19 Patient N/A
Completed NCT04419610 - RAS and Coagulopathy in COVID19 Early Phase 1
Completed NCT04546581 - Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) Phase 3
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04435327 - Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Not yet recruiting NCT04524156 - COVID-19 : Transcutaneous pO2 and pCO2 as Predictive Factors for Acute Respiratory Destress Syndrome in Patients Affected With SARS-Cov-2 N/A
Completed NCT04441710 - Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus
Completed NCT04357834 - WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories
Not yet recruiting NCT04392427 - New Antiviral Drugs for Treatment of COVID-19 Phase 3
Terminated NCT04614025 - Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19 Phase 2
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2