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People Hospitalized with COVID-19
Protocol: SITE00000172
Full Title
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
Description
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.

Technical Description

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


Keyword: COVID-19
Compensation: No
Eligibility
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.
Age Group: Adults
Principal Investigator: CARLA FREDERICK
Contact(s)
CATHERINE WRONA
wrona@buffalo.edu
+1 716-888-4713
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Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.