British journal of clinical pharmacology · 2022
The effect of TRV027 on coagulation in COVID-19: A pilot randomized, placebo-controlled trial.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Robbins Alexander J, Che Bakri Nur Amalina, Toke-Bjolgerud Edward, Edwards Aaron, Vikraman Asha, Michalsky Cathy, Fossler Michael, Lemm Nana-Marie, Medhipour Savviz, Budd William, Gravani Athanasia, Hurley Lisa, Kapil Vikas, Jackson Aimee, Lonsdale Dagan, Latham Victoria, Laffan Michael, Chapman Neil, Cooper Nichola, Szydlo Richard, Boyle Joseph, Pollock Katrina M, Owen David
Аннотация
COVID-19 causes significant thrombosis and coagulopathy, with elevated D-dimer a predictor of adverse outcome. The precise mechanism of this coagulopathy remains unclear; one hypothesis is that loss of angiotensin-converting enzyme 2 activity during viral endocytosis leads to pro-inflammatory angiotensin-II accumulation, loss of angiotensin-1-7 and subsequent vascular endothelial activation. We undertook a double-blind randomized, placebo-controlled experimental medicine study to assess the effect of TRV027, a synthetic angiotensin-1-7 analogue on D-dimer in 30 patients admitted to hospital with COVID-19. The study showed a similar rate of adverse events in TRV027 and control groups. There was a numerical decrease in D-dimer in the TRV027 group and increase in D-dimer in the placebo group; however, this did not reach statistical significance (P = .15). A Bayesian analysis demonstrated that there was a 92% probability that this change represented a true drug effect.