A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF APL-9 IN MILD TO MODERATE ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO COVID-19
This study enrolls people who are currently hospitalized due to COVID-19. The purpose of this study is to learn about the safety and effectiveness of an investigational drug called APL-9. We want to know if this investigational drug helps patients recover from COVID-19 related lung inflammation faster.
You will have an IV infusion with the study drug (APL-9) or placebo (saline). It will be given continuously during part of your hospital stay via your IV. You will have tests done several times, like having nose and saliva samples taken, urine samples, and having blood drawn. Some follow up visits can be done in your home or electronically. Study takes place at Buffalo General medical Center.
The primary objective of this study is to evaluate the safety of APL-9 compared with that of vehicle control (as add-on therapy to SOC) in subjects with COVID-19 who have mild to moderate ARDS Site For Apellis
Adults ages 18+.
Confirmed COVID-19 infection.
Diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) and need mechanical ventilation.
Have not been treated with convalescent plasma for COVID-19.
No evidence of kidney or liver failure.
Due to COVID-19, new enrollment in research studies will be greatly limited.
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