Open AccessRandomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Author(s) -
Cohen Jordana B.,
Hanff Thomas C.,
CorralesMedina Vicente,
William Preethi,
Renicolas,
RosadoSantander Nelson R.,
RodriguezMori Juan E.,
Spaak Jonas,
AndradeVillanueva Jaime,
Chang Tara I.,
Barbagelata Alejandro,
Alfonso Carlos E.,
BernalesSalas Eduardo,
Coacalla Johanna,
CastroCallirgos Carlos Augusto,
TupayachiVenero Karen E.,
Medina Carola,
Valdivia Renzo,
Villavicencio Mirko,
Vasquez Charles R.,
Harhay Michael O.,
Chittams Jesse,
Sharkoski Tiffany,
Byrd James Brian,
Edmonston Daniel L.,
Sweitzer Nancy,
Chirinos Julio A.
Publication year - 2020
Publication title -
the journal of clinical hypertension
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.909
H-Index - 67
eISSN - 1751-7176
pISSN - 1524-6175
DOI - 10.1111/jch.14011
Subject(s) - medicine , randomized controlled trial , institutional review board , covid-19 , mechanical ventilation , angiotensin receptor blockers , log rank test , intensive care medicine , renin–angiotensin system , disease , survival analysis , surgery , blood pressure , infectious disease (medical specialty)
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.