A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
a study on COVID-19 Severe Acute Respiratory Syndrome Ards Acute Respiratory Distress Syndrome Respiratory Distress Syndrome
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedestimated completion
Description
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.
Official Title
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
Keywords
COVID Covid-19 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Ards Acute Respiratory Distress Syndrome Coronavirus Infections Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome APL-9 Isotonic saline
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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
Locations
- University of California at San Francisco - Fresno
accepting new patients
Fresno California 93701 United States - California Pacific Medical Center
accepting new patients
San Francisco California 94115 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Apellis Pharmaceuticals, Inc.
- ID
- NCT04402060
- Phase
- Phase 1/2
- Study Type
- Interventional
- Last Updated