1. The effect of TRV027 on coagulation in COVID 19: A pilot randomized, placebo-controlled controlled trial
- Author
-
Robbins, AJ, Che Bakri, NA, Toke-Bjolgerud, E, Edwards, A, Vikraman, A, Michalsky, C, Fossler, M, Lemm, N-M, Medhipour, S, Budd, W, Gravani, A, Hurley, L, Kapil, V, Jackson, A, Lonsdale, D, Latham, V, Laffan, M, Chapman, N, Cooper, N, Szydlo, R, Boyle, J, Pollock, KM, and Owen, D
- Abstract
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 randomised, 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 (REC ref. 20/HRA/3414), Clinical Trial No. NCT04419610. 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=0.15). A Bayesian analysis demonstrated there was a 92% probability that this change represented a true drug effect.
- Published
- 2022