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
AU - Gommans, D.H.F.
AU - Nas, J.
AU - Pinto-Sietsma, S.J.
AU - Koop, Y.
AU - Konst, R.E.
AU - Mensink, F.
AU - Aarts, G.W.A.
AU - Konijnenberg, L.S.F.
AU - Cortenbach, K.
AU - Verhaert, D.V.M.
AU - Thannhauser, J.
AU - Mol, J.Q.
AU - Rooijakkers, M.J.P.
AU - Vos, J.L.
AU - van Rumund, A.
AU - Vart, P.
AU - Hassing, R.J.
AU - Cornel, J.H.
AU - de Jager, C.P.C.
AU - van den Heuvel, M.M.
AU - van der Hoeven, H.G.
AU - Verbon, A.
AU - Pinto, Y.M.
AU - van Royen, N.
AU - van Kimmenade, R.R.J.
AU - de Leeuw, P.W.
AU - van Agtmael, M.A.
AU - Bresser, P.
AU - van Gilst, W.H.
AU - Vonk-Noordergraaf, A.
AU - Tijssen, J.G.P.
AU - Data Safety Monitoring Board
AU - Event Committee
AU - Steering Comm
N1 - Funding Information:
Funding: This work is supported by the Netherlands Heart Institute , the Dutch Heart Foundation , the Dutch CardioVascular Alliance , and Novartis Pharma BV .
Funding Information:
Funding: This work is supported by the Netherlands Heart Institute, the Dutch Heart Foundation, the Dutch CardioVascular Alliance, and Novartis Pharma BV.Radboud Technology Centre of Clinical Studies (Nijmegen, the Netherlands) will be responsible for data monitoring. Monitoring will be done according to a predefined monitoring plan in accordance with the prevailing guidelines. The review and adjudication of all primary end points will be conducted by an independent event adjudication committee blinded for study group. This work is supported by the Netherlands Heart Institute, the Dutch Heart Foundation, the Dutch CardioVascular Alliance, and Novartis Pharma BV.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/8/1
Y1 - 2020/8/1
N2 - 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.
AB - 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.
KW - ace2
KW - angiotensin-converting enzyme-2
KW - coronavirus
KW - receptor
KW - sars
KW - ANGIOTENSIN-CONVERTING ENZYME-2
KW - ACE2
KW - RECEPTOR
KW - SARS
KW - CORONAVIRUS
U2 - 10.1016/j.ahj.2020.05.010
DO - 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 -