Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/41422
CONTINUING VERSUS SUSPENDING ANGIOTENSIN-CONVERTING ENZYME INHIBITORS AND ANGIOTENSIN RECEPTOR BLOCKERS: IMPACT ON ADVERSE OUTCOMES IN HOSPITALIZED PATIENTS WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2)
Author
Lopes, Renato D.
Macedo, Ariane Vieira Scarlatelli
Silva, Pedro Gabriel Melo de Barros e
Moll-Bernardes, Renata Junqueira
Feldman, Andre
D'Andréa Saba Arruda, Guilherme
Souza, Andrea Silvestre de
Albuquerque, Denilson Campos de
Mazza, Lilian
Santos, Mayara Fraga
Salvador, Natalia Zerbinatti
Gibson, C. Michael
Granger, Christopher B.
Alexander, John H.
Souza, Olga Ferreira de
Macedo, Ariane Vieira Scarlatelli
Silva, Pedro Gabriel Melo de Barros e
Moll-Bernardes, Renata Junqueira
Feldman, Andre
D'Andréa Saba Arruda, Guilherme
Souza, Andrea Silvestre de
Albuquerque, Denilson Campos de
Mazza, Lilian
Santos, Mayara Fraga
Salvador, Natalia Zerbinatti
Gibson, C. Michael
Granger, Christopher B.
Alexander, John H.
Souza, Olga Ferreira de
Affilliation
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Duke University Medical Center. Duke Clinical Research Institute. Durham, NC, USA / Brazilian Clinical Research Institute, São Paulo, SP, Brasil / Rede D'Or São Luiz, São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil / Santa Casa de São Paulo. São Paulo, SP, Brasil.
Brazilian Clinical Research Institute, São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brazil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Harvard Medical School, Boston, MA, USA.
Brazilian Clinical Research Institute, São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Harvard Medical School, Boston, MA, USA.
Duke University Medical Center. Duke Clinical Research Institute. Durham, NC, USA.
Duke University Medical Center. Duke Clinical Research Institute. Durham, NC, USA.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil / Santa Casa de São Paulo. São Paulo, SP, Brasil.
Brazilian Clinical Research Institute, São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Universidade Federal do Rio de Janeiro. Rio de Janeiro, RJ, Brazil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Harvard Medical School, Boston, MA, USA.
Brazilian Clinical Research Institute, São Paulo, SP, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil.
Harvard Medical School, Boston, MA, USA.
Duke University Medical Center. Duke Clinical Research Institute. Durham, NC, USA.
Duke University Medical Center. Duke Clinical Research Institute. Durham, NC, USA.
Instituto D'Or de Pesquisa e Ensino. Rio de Janeiro, RJ, Brasil / Rede D'Or São Luiz. São Paulo, SP, Brasil.
Abstract
Angiotensin-converting enzyme-2 (ACE2) may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain.DESIGNBRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 32 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels.
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