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.
Am Heart J
; 226: 60-68, 2020 08.
Article
em En
| MEDLINE
| ID: mdl-32512291
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 11 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 11 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.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Pneumonia Viral
/
Síndrome do Desconforto Respiratório
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Infecções por Coronavirus
/
Unidades de Cuidados Coronarianos
/
Bloqueadores do Receptor Tipo 1 de Angiotensina II
/
Valsartana
/
Betacoronavirus
Tipo de estudo:
Clinical_trials
Limite:
Adult
/
Humans
País como assunto:
Europa
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article