NCT04402060
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
PHASE1
PHASE2
COMPLETED
NCT04402060
INTERVENTIONAL
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
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.
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
COVID
Covid-19
Coronavirus
Coronavirus Infection
Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome Coronavirus 2
Sars-CoV2
Ards
Acute Respiratory Distress Syndrome
- TREATMENT
-
- Type: DRUG
- Name: APL-9
- Description: Complement (C3) Inhibitor
- Arm Group Labels: 180 mg APL-9 IV plus SOC
-
- Type: OTHER
- Name: Vehicle Control
- Description: Normal saline of equal volume to active arm
- Arm Group Labels: Isotonic saline plus SOC
- Apellis Pharmaceuticals, Inc.