A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Status:
Completed
Trial end date:
2021-02-19
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with
mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are
hospitalized and require supplemental oxygen therapy with or without mechanical ventilation.
It is thought that COVID-19 activates the complement system, part of the immune system that
responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has
been designed to inhibit or block activation of part of the complement pathway, and
potentially reduce inflammation in the lungs.
Part 1 of the study is open-label to evaluate safety; all participants will receive APL-9
plus standard of care. Part 2 of the study is double-blind, randomized; participants will
receive either APL-9 or the vehicle-control plus standard of care.