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.
Drug: APL-9
Complement (C3) Inhibitor
Other: Vehicle Control
Normal saline of equal volume to active arm
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
University of California at San Francisco - Fresno
Fresno, California, United States
California Pacific Medical Center
San Francisco, California, United States
Baptist Medical Center Beaches
Jacksonville Beach, Florida, United States
Westchester General Hospital
Miami, Florida, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Lutheran Health Physicians
Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, United States
Norton Audobon Hospital
Louisville, Kentucky, United States
Cambridge Medical Trials
Alexandria, Louisiana, United States
Ascension Providence Hospital
Southfield, Michigan, United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University at Buffalo
Buffalo, New York, United States
Columbia University
New York, New York, United States
Texas A&M College of Medicine - Scott and White
Temple, Texas, United States
Hospital Angelina Caron
Campina Grande Do Sul, Paraná, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Estadual Mario Covas
Santo André, Sao Paulo, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP
São Bernardo Do Campo, Sao Paulo, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Sao Paulo, Brazil
Hospital Santa Marcelina
São Paulo, Sao Paulo, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, São Paulo, Brazil