TY - JOUR
T1 - Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
AU - Cohen, Jordana B.
AU - Hanff, Thomas C.
AU - Corrales-Medina, Vicente
AU - William, Preethi
AU - Renna, Nicolas
AU - Rosado-Santander, Nelson R.
AU - Rodriguez-Mori, Juan E.
AU - Spaak, Jonas
AU - Andrade-Villanueva, Jaime
AU - Chang, Tara I.
AU - Barbagelata, Alejandro
AU - Alfonso, Carlos E.
AU - Bernales-Salas, Eduardo
AU - Coacalla, Johanna
AU - Castro-Callirgos, Carlos Augusto
AU - Tupayachi-Venero, Karen E.
AU - Medina, Carola
AU - Valdivia, Renzo
AU - Villavicencio, Mirko
AU - Vasquez, Charles R.
AU - Harhay, Michael O.
AU - Chittams, Jesse
AU - Sharkoski, Tiffany
AU - Byrd, James Brian
AU - Edmonston, Daniel L.
AU - Sweitzer, Nancy
AU - Chirinos, Julio A.
N1 - Publisher Copyright:
© 2020 Wiley Periodicals LLC
PY - 2020/10/1
Y1 - 2020/10/1
N2 - 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.
AB - 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.
KW - COVID-19
KW - angiotensin receptor blocker
KW - angiotensin-converting enzyme inhibitor
KW - angiotensin-converting enzyme inhibitor 2
KW - clinical trial
KW - coronavirus
KW - hypertension
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U2 - 10.1111/jch.14011
DO - 10.1111/jch.14011
M3 - Article
C2 - 32937008
AN - SCOPUS:85090972922
SN - 1524-6175
VL - 22
SP - 1780
EP - 1788
JO - Journal of Clinical Hypertension
JF - Journal of Clinical Hypertension
IS - 10
ER -