A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Public ClinicalTrials.gov record NCT04402060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04402060
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 27, 2020
- Primary completion
- Feb 12, 2021
- Completion
- Feb 12, 2021
- Last update posted
- Mar 22, 2022
2020 – 2021
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco - Fresno | Fresno | California | 93701 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| Baptist Medical Center Beaches | Jacksonville Beach | Florida | 32250 | — |
| Westchester General Hospital | Miami | Florida | 40241 | — |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Lutheran Health Physicians | Fort Wayne | Indiana | 46804 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | — |
| Norton Audobon Hospital | Louisville | Kentucky | 40217 | — |
| Cambridge Medical Trials | Alexandria | Louisiana | 71301 | — |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | — |
| Rutgers University - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| University at Buffalo | Buffalo | New York | 14203 | — |
| Columbia University | New York | New York | 10032 | — |
| Texas A&M College of Medicine - Scott and White | Temple | Texas | 76508 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04402060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 22, 2022 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04402060 live on ClinicalTrials.gov.