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American heart journal · Aug 2020
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.
- D H Frank Gommans, Joris Nas, Sara-Joan Pinto-Sietsma, Yvonne Koop, Regina E Konst, Frans Mensink, Goaris W A Aarts, Lara S F Konijnenberg, Kimberley Cortenbach, Verhaert Dominique V M DVM Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Jos Thannhauser, Jan-Quinten Mol, Maxim J P Rooijakkers, Jacqueline L Vos, Anouke van Rumund, Priya Vart, Robert-Jan Hassing, Jan-Hein Cornel, C Peter C de Jager, Michel M van den Heuvel, Hans G van der Hoeven, Annelies Verbon, Yigal M Pinto, Niels van Royen, van Kimmenade Roland R J RRJ Department of Cardiology, Radboudumc, Nijmegen, the Netherlands., Event committee, Peter W de Leeuw, Michiel A van Agtmael, Paul Bresser, Data Safety Monitoring Board, Wiek H van Gilst, Anton Vonk-Noordergraaf, Tijssen Jan G P JGP Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands., and Steering committee.
- Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.
- Am. Heart J. 2020 Aug 1; 226: 60-68.
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. MethodsThe 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). SummaryThe 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.Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
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