NCT04402060|CompletedPhase 1/2ResultsDMCFDA Drug
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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
Sponsor study identifier
interventional
72
2 countries
24
Study Start
May 28, 2020
Actual (reported)Primary Completion
February 13, 2021
Actual (reported)Study Completion
February 13, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 13, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 22, 2020
Actual (reported)May 26, 2020
Actual (reported)May 28, 2020
Actual (reported)February 13, 2021
Actual (reported)February 13, 2021
Actual (reported)March 23, 2022
Actual (reported)Number of Subjects Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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 disruption of the ability to conduct normal life functions; or a congenital anomaly/birth defect.
From the first dose of study drug and up to 30 (+7) days after the last dose of study drug. Part 1: Day 1 up to Day 44; Part 2: Day 1 up to Day 58
Hospital Length of Stay
Part 2: Day 1 up to Day 58
Complement (C3) Inhibitor
Normal saline of equal volume to active arm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of California at San Francisco - Fresno
Fresno, California, 93701, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Baptist Medical Center Beaches
Jacksonville Beach, Florida, 32250, United States
Westchester General Hospital
Miami, Florida, 40241, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Lutheran Health Physicians
72 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2020
First Posted
May 26, 2020
Study Start
May 28, 2020
Actual (reported)Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
Overall Survival
Part 2: Day 1 up to Day 58 (until the safety follow-up assessment 30 days after last study treatment [+7 days])
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score Over Time
Part 2: Baseline (Day 1) and Days 3, 5, 7, 11, 15 and end of treatment (EOT) visit (up to Day 21)
Total Duration of Mechanical Ventilation
Part 2: Day 1 up to Day 58
Total Duration of Oxygen Therapy
Part 2: Day 1 up to Day 58
Contact the study team to confirm eligibility.
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207, United States
Norton Audobon Hospital
Louisville, Kentucky, 40217, United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301, United States
Ascension Providence Hospital
Southfield, Michigan, 48075, United States
Rutgers University - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
University at Buffalo
Buffalo, New York, 14203, United States
Columbia University
New York, New York, 10032, United States
Texas A&M College of Medicine - Scott and White
Temple, Texas, 76508, United States
Hospital Angelina Caron
Campina Grande do Sul, Paraná, 83430-000, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 91530-001, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, São Paulo, 18618-686, Brazil
Hospital Estadual Mario Covas
Santo André, São Paulo, 09190-615, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP
São Bernardo do Campo, São Paulo, 0917-090, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-020, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-120, Brazil
Primary Completion
February 13, 2021
Actual (reported)Study Completion
February 13, 2021
Actual (reported)Last Updated
March 23, 2022
Results First Posted
March 23, 2022
Record last verified: 2022-03
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Source: ClinicalTrials.gov.
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