The effect of TRV027 on coagulation in COVID-19: A pilot randomized, placebo-controlled trial.

British journal of clinical pharmacology 2023 Apr

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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. © 2022 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Citation

Alexander J Robbins, Nur Amalina Che Bakri, Edward Toke-Bjolgerud, Aaron Edwards, Asha Vikraman, Cathy Michalsky, Michael Fossler, Nana-Marie Lemm, Savviz Medhipour, William Budd, Athanasia Gravani, Lisa Hurley, Vikas Kapil, Aimee Jackson, Dagan Lonsdale, Victoria Latham, Michael Laffan, Neil Chapman, Nichola Cooper, Richard Szydlo, Joseph Boyle, Katrina M Pollock, David Owen. The effect of TRV027 on coagulation in COVID-19: A pilot randomized, placebo-controlled trial. British journal of clinical pharmacology. 2023 Apr;89(4):1495-1501