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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 SARS-CoV-2, sponsored by Apellis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04402060: Completed Phase 1 study of COVID-19 and SARS-CoV-2, sponsored by Apellis Pharmaceuticals.
NCT04402060 is a Phase 1 study of COVID-19 and SARS-CoV-2 that has completed, run by Apellis Pharmaceuticals. The registered enrollment target is 72 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04402060, a Phase 1 study of COVID-19 and SARS-CoV-2, 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.
Primary Outcome
TEAEs were defined as those adverse events that developed or worsened in severity after initiation of the first dose of study drug and up to 30 (+7) days beyond the last dose of study drug. A serious TEAE was any TEAE or suspected adverse reaction that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes: death; is life threatening; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial
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 |
What the finished NCT04402060 record still lists
NCT04402060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
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 names 20 study sites across 14 states, led by 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, SARS-CoV-2, Acute Respiratory Distress Syndrome, Corona Virus Infection, Coronavirus.
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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