Status:
COMPLETED
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Lead Sponsor:
Apellis Pharmaceuticals, Inc.
Conditions:
COVID
Covid-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2021
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04402060
Start Date
May 28 2020
End Date
February 13 2021
Last Update
March 23 2022
Active Locations (24)
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1
University of California at San Francisco - Fresno
Fresno, California, United States, 93701
2
California Pacific Medical Center
San Francisco, California, United States, 94115
3
Baptist Medical Center Beaches
Jacksonville Beach, Florida, United States, 32250
4
Westchester General Hospital
Miami, Florida, United States, 40241