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A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
NCT04402060 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- OTHER Vehicle Control
- DRUG APL-9
Study Locations (20)
California
- University of California at San Francisco - Fresno — Fresno
- California Pacific Medical Center — San Francisco
Florida
- Baptist Medical Center Beaches — Jacksonville Beach
- Westchester General Hospital — Miami
Illinois
- Northwestern University, Feinberg School of Medicine — Chicago
- Loyola University Medical Center — Maywood
Kentucky
- Norton Women's and Children's Hospital — Louisville
- Norton Audobon Hospital — Louisville
New York
- University at Buffalo — Buffalo
- Columbia University — New York
Rio Grande do Sul
- Irmandade da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
- Hospital São Lucas da PUCRS — Porto Alegre
Indiana
- Lutheran Health Physicians — Fort Wayne
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2021-02-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04402060
The ClinicalTrials.gov registry entry for NCT04402060 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apellis Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Vehicle Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04402060 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04402060 about?
NCT04402060 is a clinical study titled "A Study of APL-9 in Adults With Mild to Moderate ARDS 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-...
What is the current status of trial NCT04402060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2020-05-28. Estimated completion is 2021-02-13.
What conditions does trial NCT04402060 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Coronavirus, COVID, Covid-19, Coronavirus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04402060?
The interventions under investigation include: Vehicle Control (OTHER), APL-9 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04402060?
This trial is sponsored by Apellis Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04402060 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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