Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PR evention of A cute r E spira TOR y d I stress syndrome in hospit A lized patie N ts with SARS- COV -2 I nfection D isease

BackgroundThere 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...

Full description

Saved in:
Bibliographic Details
Published in:The American heart journal 2020-08, Vol.226, p.60
Main Authors: Gommans, D H Frank, Nas, Joris, Pinto-Sietsma, Sara-Joan, Koop, Yvonne, Konst, Regina E, Mensink, Frans, Goaris WA Aarts, Lara SF Konijnenberg, Cortenbach, Kimberley, Verhaert, Dominique VM, Thannhauser, Jos, Jan-Quinten Mol, Rooijakkers, Maxim JP, Vos, Jacqueline L, Anouke van Rumund, Vart, Priya, Robert-Jan Hassing, Jan-Hein, Cornel, C Peter C de Jager, Michel M van den Heuvel, Hans G van der Hoeven, Verbon, Annelies, Pinto, Yigal M, Niels van Royen, Roland RJ van Kimmenade, de Leeuw, Peter W, van Agtmael, Michiel A, Bresser, Paul, van Gilst, Wiek H, Vonk-Noordergraaf, Anton, Tijssen, Jan GP
Format: Article
Language:English
Subjects:
Angiotensin
Angiotensin II
Blood pressure
Cardiology
Clinical trials
Coronaviruses
COVID-19
Double-blind studies
Fibrosis
Health services
Heart
Hospitals
Infections
Infectious diseases
Injury prevention
Lung diseases
Mechanical ventilation
Mortality
Patients
Permeability
Quality of life
Questionnaires
Respiratory diseases
Severe acute respiratory syndrome
Severe acute respiratory syndrome coronavirus 2
Ventilation
Ventilators
Viral diseases
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:BackgroundThere 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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2020.05.010