NCT04402060

A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19

A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID
• Covid-19
• Coronavirus
• Coronavirus Infection
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Sars-CoV2
• Ards
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	APL-9	Complement (C3) Inhibitor
OTHER	Vehicle Control	Normal saline of equal volume to active arm

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-02-13
• Completion: 2021-02-13
• First posted: 2020-05-26
• Last updated: 2022-03-23
• Results posted: 2022-03-23

Locations

24 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study