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

Completed · Phase 1/Phase 2

Conditions studied: COVID, Covid-19, Coronavirus, Coronavirus Infection, Severe Acute Respiratory Syndrome, Severe Acute Respiratory Syndrome Coronavirus 2, Sars-CoV2, Ards, Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT04402060

Run by

Apellis Pharmaceuticals, Inc.

People needed

72

Starts

2020-05-28

Expected to finish

2021-02-13

Last updated by the study team

2022-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• 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
• UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP — Botucatu, São Paulo, Brazil
• Hospital Estadual Mario Covas — Santo André, São Paulo, Brazil
• CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP — São Bernardo do Campo, São Paulo, Brazil
• Hospital Alemao Oswaldo Cruz — São Paulo, São Paulo, Brazil
• Hospital Santa Marcelina — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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