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NCT04402060 · ClinicalTrials.gov registry record · Phase 1
A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
A Phase 1 study of COVID-19 and Acute Respiratory Distress Syndrome, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04402060 is a Phase 1 study of COVID-19 and Acute Respiratory Distress Syndrome that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 72 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04402060, a Phase 1 study of COVID-19 and Acute Respiratory Distress Syndrome, has completed, sponsored by Apellis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Apellis Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Vehicle Control is the first listed.
NCT04402060 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Illinois.
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: COVID-19, Acute Respiratory Distress Syndrome, Coronavirus, ARDS, COVID.
What interventions are being tested in trial NCT04402060?
The interventions under investigation include: Vehicle Control (OTHER), APL-9 (DRUG).
Who is sponsoring clinical trial NCT04402060?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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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