A Study of the C3 Inhibitor AMY-101 in Patients With ARDS Due to COVID-19 (SAVE)
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The study is a prospective, randomized, placebo-controlled, single-blind phase 2 clinical
study of the efficacy and safety of AMY-101, a potent C3 inhibitor, for the management of
patients with ARDS caused by SARS-CoV-2 infection.
We will assess the efficacy and safety, as well as pharmacokinetics (PK), and
pharmacodynamics (PD). The study will assess the impact of AMY-101 in patients with severe
COVID19; specifically, it will assess the impact of AMY-101 1) on survival without ARDS and
without oxygen requirement at day 21 and 2) on the clinical status of the patients at day 21.