TY - JOUR
T1 - Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease: PRAETORIAN-COVID (NCT04335786)
T2 - A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease: PRAETORIAN-COVID (NCT04335786)
AU - Gommans, D. H. Frank
AU - Nas, Joris
AU - Pinto-Sietsma, Sara-Joan
AU - Koop, Yvonne
AU - Konst, Regina E.
AU - Mensink, Frans
AU - Aarts, Goaris W. A.
AU - Konijnenberg, Lara S. F.
AU - Cortenbach, Kimberley
AU - Verhaert, Dominique V. M.
AU - Thannhauser, Jos
AU - Mol, Jan-Quinten
AU - Rooijakkers, Maxim J. P.
AU - Vos, Jacqueline L.
AU - van Rumund, Anouke
AU - Vart, Priya
AU - Hassing, Robert-Jan
AU - Cornel, Jan-Hein
AU - de Jager, C. Peter C.
AU - van den Heuvel, Michel M.
AU - van der Hoeven, Hans G.
AU - Verbon, Annelies
AU - Pinto, Yigal M.
AU - van Royen, Niels
AU - van Kimmenade, Roland R. J.
AU - de Leeuw, Peter W.
AU - van Agtmael, Michiel A.
AU - Event committee
AU - Bresser, Paul
AU - Data Safety Monitoring Board
AU - van Gilst, Wiek H.
AU - Steering committee
AU - Vonk-Noordergraaf, Anton
AU - Tijssen, Jan G. P.
PY - 2020/8/1
Y1 - 2020/8/1
N2 - There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome–coronavirus-2 (SARS-CoV-2)–infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II–mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. Methods: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2–infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2–infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.
AB - There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome–coronavirus-2 (SARS-CoV-2)–infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II–mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. Methods: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2–infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2–infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.
UR - http://www.scopus.com/inward/record.url?scp=85085741049&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ahj.2020.05.010
DO - https://doi.org/10.1016/j.ahj.2020.05.010
M3 - Article
C2 - 32512291
SN - 0002-8703
VL - 226
SP - 60
EP - 68
JO - American Heart Journal
JF - American Heart Journal
ER -