Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for evention of cute rspiray dstress syndrome in hospitlized patiets with SARS--2 nfection isease - 16/08/20
, Joris Nas, MD a, Sara-Joan Pinto-Sietsma, MD, PhD b, Yvonne Koop, RN, MSc a, Regina E. Konst, MD a, Frans Mensink, MD a, Goaris W.A. Aarts, MD a, Lara S.F. Konijnenberg, MD a, Kimberley Cortenbach, MD a, Dominique V.M. Verhaert, MD a, c, Jos Thannhauser, MSc a, Jan-Quinten Mol, MD a, Maxim J.P. Rooijakkers, MD a, Jacqueline L. Vos, MD a, Anouke van Rumund, MD d, Priya Vart, PhD e, Robert-Jan Hassing, MD, PhD f, Jan-Hein Cornel, MD, PhD a, g, C. Peter C. de Jager, MD, PhD h, Michel M. van den Heuvel, MD, PhD i, Hans G. van der Hoeven, MD, PhD j, Annelies Verbon, MD, PhD k, Yigal M. Pinto, MD, PhD l, Niels van Royen, MD, PhD a, Roland R.J. van Kimmenade, MD, PhD aEvent committee
Peter W. de Leeuw, MD, PhD (chair) m, Michiel A. van Agtmael, MD, PhD n, Paul Bresser, MD, PhD o,Data Safety Monitoring Board
Wiek H. van Gilst, MD, PhD (chair) p, Anton Vonk-Noordergraaf, MD, PhD q, Jan G.P. Tijssen, PhD l,Steering committee
Niels van Royen, MD, PhD (chair) a, C. Peter C. de Jager, MD, PhD h, Michel M. van den Heuvel, MD, PhD i, Hans G. van der Hoeven, MD, PhD j, Annelies Verbon, MD, PhD k, Yigal M. Pinto, MD, PhD l, Roland R.J. van Kimmenade, MD, PhD a
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Background |
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).
Summary |
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.
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| Funding: This work is supported by the Netherlands Heart Institute, the Dutch Heart Foundation, the Dutch CardioVascular Alliance, and Novartis Pharma BV. |
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| Declaration of interest: All authors have provided conflict of interest forms. |
Vol 226
P. 60-68 - Agosto 2020 Ritorno al numero
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