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Deprecated: Implicit conversion from float 330.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Am+Heart+J 2020 ; 226 (ä): 60-68 Nephropedia Template TP
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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 #MMPMID32512291
Gommans DHF; Nas J; Pinto-Sietsma SJ; Koop Y; Konst RE; Mensink F; Aarts GWA; Konijnenberg LSF; Cortenbach K; Verhaert DVM; Thannhauser J; Mol JQ; Rooijakkers MJP; Vos JL; van Rumund A; Vart P; Hassing RJ; Cornel JH; de Jager CPC; van den Heuvel MM; van der Hoeven HG; Verbon A; Pinto YM; van Royen N; van Kimmenade RRJ; de Leeuw PW; van Agtmael MA; Bresser P; van Gilst WH; Vonk-Noordergraaf A; Tijssen JGP; van Royen N; de Jager CPC; van den Heuvel MM; van der Hoeven HG; Verbon A; Pinto YM; van Kimmenade RRJ
Am Heart J 2020[Aug]; 226 (ä): 60-68 PMID32512291show ga
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.
|*Betacoronavirus[MESH]
|*Coronary Care Units[MESH]
|*Randomized Controlled Trials as Topic[MESH]
|Adult[MESH]
|Angiotensin II Type 1 Receptor Blockers/administration & dosage/*therapeutic use[MESH]