Title
Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Date Issued
01 October 2020
Access level
open access
Resource Type
journal article
Author(s)
Cohen J.B.
Hanff T.C.
Corrales-Medina V.
William P.
Renna N.
Rosado-Santander N.R.
Rodriguez-Mori J.E.
Spaak J.
Andrade-Villanueva J.
Chang T.I.
Barbagelata A.
Alfonso C.E.
Bernales-Salas E.
Coacalla J.
Castro-Callirgos C.A.
Tupayachi-Venero K.E.
Medina C.
Villavicencio M.
Vasquez C.R.
Harhay M.O.
Chittams J.
Sharkoski T.
Byrd J.B.
Edmonston D.L.
Sweitzer N.
Chirinos J.A.
Publisher(s)
Blackwell Publishing Inc.
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.
Start page
1780
End page
1788
Volume
22
Issue
10
Language
English
OCDE Knowledge area
Enfermedades infecciosas Sistema respiratorio
Scopus EID
2-s2.0-85090972922
PubMed ID
Source
Journal of Clinical Hypertension
ISSN of the container
15246175
Sponsor(s)
The study was funded by JBC (K23‐HL133843); TCH (T32‐HL007891) JAC (R01‐HL 121510‐01A1, R61‐HL‐146390, R01‐AG058969, 1R01‐HL104106, P01‐HL094307, R03‐HL146874‐01, and R56‐HL136730) CRV (T32‐DK07785); and MOH (R00‐HL141678). The study was funded by JBC (K23-HL133843); TCH (T32-HL007891) JAC (R01-HL 121510-01A1, R61-HL-146390, R01-AG058969, 1R01-HL104106, P01-HL094307, R03-HL146874-01, and R56-HL136730) CRV (T32-DK07785); and MOH (R00-HL141678). The authors would like to thank the members of the Data Safety Monitoring Board for their oversight of the trial: John Younger, MD; Raymond R. Townsend, MD; Gustavo Heresi, MD, MS; Todd A. Miano, PharmD, PhD; and Jesse Yenchih Hsu, PhD, MS.
Sources of information: Directorio de Producción Científica Scopus