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.

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  • Additional Information
    • Corporate Authors:
      Event committee; Data Safety Monitoring Board; Steering committee
    • Source:
      Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
    • Publication Information:
      Original Publication: St. Louis, MO : Mosby
    • Subject Terms:
      Betacoronavirus* ; Coronary Care Units* ; Randomized Controlled Trials as Topic*; Angiotensin II Type 1 Receptor Blockers/*therapeutic use ; Coronavirus Infections/*complications ; Pneumonia, Viral/*complications ; Respiratory Distress Syndrome/*prevention & control ; Valsartan/*therapeutic use; Adult ; Angiotensin II Type 1 Receptor Blockers/administration & dosage ; COVID-19 ; Coronavirus Infections/mortality ; Double-Blind Method ; Drug Administration Schedule ; Humans ; Inpatients ; Multicenter Studies as Topic ; Netherlands ; Pandemics ; Placebos/therapeutic use ; Pneumonia, Viral/mortality ; Respiration, Artificial ; Respiratory Distress Syndrome/mortality ; SARS-CoV-2 ; Time Factors ; Valsartan/administration & dosage
    • Abstract:
      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.
      (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)
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    • Molecular Sequence:
      ClinicalTrials.gov NCT04335786
    • Accession Number:
      0 (Angiotensin II Type 1 Receptor Blockers)
      0 (Placebos)
      80M03YXJ7I (Valsartan)
    • Publication Date:
      Date Created: 20200609 Date Completed: 20200826 Latest Revision: 20240731
    • Publication Date:
      20240731
    • Accession Number:
      PMC7239793
    • Accession Number:
      10.1016/j.ahj.2020.05.010
    • Accession Number:
      32512291