Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol

Jordana B Cohen; Thomas C Hanff; Vicente Corrales-Medina; Preethi William; Nicolas Renna; Nelson R Rosado-Santander; Juan E Rodriguez-Mori; Jonas Spaak; Jaime Andrade-Villanueva; Tara I Chang; Alejandro Barbagelata; Carlos E Alfonso; Eduardo Bernales-Salas; Johanna Coacalla; Carlos Augusto Castro-Callirgos; Karen E Tupayachi-Venero; Carola Medina; Renzo Valdivia; Mirko Villavicencio; Charles R Vasquez; Michael O Harhay; Jesse Chittams; Tiffany Sharkoski; James Brian Byrd; Daniel L Edmonston; Nancy Sweitzer; Julio A Chirinos

doi:10.1111/jch.14011

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Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol

Journal article

Open access

Peer reviewed

Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol

Jordana B Cohen, Thomas C Hanff, Vicente Corrales-Medina, Preethi William, Nicolas Renna, Nelson R Rosado-Santander, Juan E Rodriguez-Mori, Jonas Spaak, Jaime Andrade-Villanueva, Tara I Chang, …

The journal of clinical hypertension (Greenwich, Conn.), Vol.22(10), pp.1780-1788

2020-10

DOI: https://doi.org/10.1111/jch.14011

PMID: 32937008

Abstract

Severity of Illness Index

Vasoconstrictor Agents - therapeutic use

COVID-19 - virology

Multiple Organ Failure - mortality

Prospective Studies

Humans

Angiotensin Receptor Antagonists - pharmacology

Hospitalization - statistics & numerical data

Male

Withholding Treatment - statistics & numerical data

Case-Control Studies

Incidence

Multiple Organ Failure - epidemiology

SARS-CoV-2 - genetics

COVID-19 - complications

Angiotensin-Converting Enzyme Inhibitors - adverse effects

Respiration, Artificial - statistics & numerical data

SARS-CoV-2 - drug effects

Adult

Female

Angiotensin-Converting Enzyme Inhibitors - pharmacology

Renal Replacement Therapy - statistics & numerical data

COVID-19 - epidemiology

Angiotensin Receptor Antagonists - adverse effects

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.

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.104 Virology - General; 1.104.1353 Coronavirus
Web Of Science research areas: Peripheral Vascular Disease
ESI research areas: Clinical Medicine

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Title: Randomized elimination and prolongation of ACE inhibitors and ARBs in coronavirus 2019 (REPLACE COVID) Trial Protocol
Creators: Jordana B Cohen - Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Thomas C Hanff - Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Vicente Corrales-Medina - Division of Infectious Diseases, University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada
Preethi William - Division of Cardiology, University of Arizona, Tucson, AZ, USA
Nicolas Renna - Hypertension Unit, Department of Pathology, Hospital Español de Mendoza, National University of Cuyo, IMBECU-CONICET, Mendoza, Argentina
Nelson R Rosado-Santander - Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú
Juan E Rodriguez-Mori - Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú
Jonas Spaak - Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden
Jaime Andrade-Villanueva - Universidad de Guadalajara, Guadalajara, Mexico
Tara I Chang - Division of Nephrology, Stanford University School of Medicine, Stanford, CA, USA
Alejandro Barbagelata - Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA
Carlos E Alfonso - Cardiology Division, University of Miami Miller School of Medicine, Miami, FL, USA
Eduardo Bernales-Salas - Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú
Johanna Coacalla - Department of Medicine, Hospital Nacional Carlos Alberto Seguín Escobedo, EsSalud, Arequipa, Perú
Carlos Augusto Castro-Callirgos - Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú
Karen E Tupayachi-Venero - Department of Nephrology, Hospital Nacional Alberto Sabogal Sologuren, EsSalud, Lima, Perú
Carola Medina - Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú
Renzo Valdivia - Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú
Mirko Villavicencio - Department of Nephrology, Hospital Nacional Edgardo Rebagliati Martins, EsSalud, Lima, Perú
Charles R Vasquez - Department of Surgery, Hospital of the University of Pennsylvania, University of Pennsylvania, Philadelphia, PA, USA
Michael O Harhay - Palliative and Advanced Illness Research (PAIR) Center and Pulmonary and Critical Care Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Jesse Chittams - Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Tiffany Sharkoski - Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
James Brian Byrd - Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA
Daniel L Edmonston - Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA
Nancy Sweitzer - Division of Cardiology, University of Arizona, Tucson, AZ, USA
Julio A Chirinos - Division of Cardiovascular Medicine, Hospital of the University of Pennsylvania and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Publication Details: The journal of clinical hypertension (Greenwich, Conn.), Vol.22(10), pp.1780-1788
Publisher: United States
Grant note: R01-AG058969 / NIH HHS R61-HL-146390 / NIH HHS T32-DK07785 / NIH HHS R00 HL141678 / NHLBI NIH HHS R01-HL 121510-01A1 / NIH HHS K23 HL133843 / NHLBI NIH HHS R01 HL104106 / NHLBI NIH HHS P01-HL094307 / NIH HHS P01 HL094307 / NHLBI NIH HHS K23-HL133843 / NIH HHS T32 DK007785 / NIDDK NIH HHS 1R01-HL104106 / NIH HHS R01 HL121510 / NHLBI NIH HHS T32-HL007891 / NIH HHS R01 HL153646 / NHLBI NIH HHS R56 HL136730 / NHLBI NIH HHS R03 HL146874 / NHLBI NIH HHS R00-HL141678 / NIH HHS R01 AG058969 / NIA NIH HHS R03-HL146874-01 / NIH HHS R56-HL136730 / NIH HHS T32 HL007891 / NHLBI NIH HHS R61 HL146390 / NHLBI NIH HHS
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Cardiovascular
Language: English
Resource Type: Journal article
PMID: 32937008
Record Identifier: 991031577386302976