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

NCT04432350 | Withdrawn

• 1 other identifier: COVID-19_TRHCPrescribeWellness
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Drug Effect; Drug Interaction; Risk Reduction

Keywords

COVID-19; Adverse Drug Event; Mortality Rate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

  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.

  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.

  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.

  1 year

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tabula Rasa HealthCare: lead

Study Sites (1)

Tabula Rasa HealthCare Precision Pharmacotherapy Research and Development Institute

Orlando, Florida, 32827, United States

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Risk Reduction Behavior; COVID-19; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Chemically-Induced Disorders

Study Officials

• Veronique Michaud

  Tabula Rasa HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: June 12, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)