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

Apellis Pharmaceuticals

Status and phase

Completed

Phase 2

Phase 1

Conditions

Sars-CoV2

COVID

Acute Respiratory Distress Syndrome

Ards

Severe Acute Respiratory Syndrome

Covid-19

Severe Acute Respiratory Syndrome Coronavirus 2

Coronavirus Infection

Coronavirus

Treatments

Drug: APL-9

Other: Vehicle Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT04402060

APL9-COV-201

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be at least 18 years of age at time of informed consent
Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio >100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.

Exclusion criteria

Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
Active bacterial, fungal, or parasitic infection
History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
Current participation in an interventional clincial trial
Subjects who have, at screening, been on mechanical ventilation for >7 days Have evidence of kidney and liver failure at screening
Have a hereditary complement deficiency
Pregnancy or breastfeeding