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Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Jordana B Cohen1,2, Thomas C Hanff2,3, Vicente Corrales-Medina4
1Renal-Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Abstract:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with high incidence of multiorgan dysfunction and death. Angiotensin-converting enzyme 2 (ACE2), which facilitates SARS-CoV-2 host cell entry, may be impacted by angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), two commonly used antihypertensive classes. In a multicenter, international randomized controlled trial that began enrollment on March 31, 2020, participants are randomized to continuation vs withdrawal of their long-term outpatient ACEI or ARB upon hospitalization with COVID-19. The primary outcome is a hierarchical global rank score incorporating time to death, duration of mechanical ventilation, duration of renal replacement or vasopressor therapy, and multiorgan dysfunction severity. Approval for the study has been obtained from the Institutional Review Board of each participating institution, and all participants will provide informed consent. A data safety monitoring board has been assembled to provide independent oversight of the project.
Insights
This study investigates if continuing or stopping angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) affects outcomes for patients hospitalized with COVID-19. Results will inform treatment guidelines for hypertension patients with SARS-CoV-2 infection.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19, leading to multiorgan dysfunction and death.
- Angiotensin-converting enzyme 2 (ACE2) is crucial for SARS-CoV-2 entry into host cells.
- Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are common antihypertensives that may influence ACE2 activity.
Purpose of the Study:
- To determine the impact of continuing versus withdrawing ACEIs or ARBs on clinical outcomes in hospitalized COVID-19 patients.
- To evaluate the safety and efficacy of maintaining or discontinuing these antihypertensive medications during SARS-CoV-2 infection.
Main Methods:
- A multicenter, international randomized controlled trial.
- Participants hospitalized with COVID-19 were randomized to either continue or withdraw their ACEI or ARB.
- Primary outcome measured by a hierarchical global rank score including mortality, mechanical ventilation, renal/vasopressor support, and organ dysfunction.
Main Results:
- Data collection and analysis are ongoing.
- The study is designed to provide robust evidence on the management of ACEIs/ARBs in COVID-19.
Conclusions:
- The findings will guide clinical decisions regarding the use of ACEIs and ARBs in patients with COVID-19.
- This research addresses a critical question in managing cardiovascular comorbidities during the pandemic.
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