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)

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, Dominique V.M. Verhaert, 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 HeuvelHans G. van der Hoeven, Annelies Verbon, Yigal M. Pinto, Niels van Royen, Roland R.J. van Kimmenade, Peter W. de Leeuw, Michiel A. van Agtmael, Paul Bresser, Wiek H. van Gilst, Anton Vonk-Noordergraaf, Jan G.P. Tijssen, Event committee, Data Safety Monitoring Board, Steering committee

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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.

Original languageEnglish
Pages (from-to)60-68
Number of pages9
JournalAmerican Heart Journal
Publication statusPublished - Aug 2020

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