A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19

NCT04402060 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: APL9-COV-201
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 24

Brief 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

COVID; Covid-19; Coronavirus; Coronavirus Infection; Severe Acute Respiratory Syndrome; Severe Acute Respiratory Syndrome Coronavirus 2; Sars-CoV2; Ards; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Hospital Length of Stay

  Part 2: Day 1 up to Day 58

• 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

Study Arms (2)

180 mg APL-9 IV plus SOC

EXPERIMENTAL

Drug: APL-9

Isotonic saline plus SOC

PLACEBO COMPARATOR

Other: Vehicle Control

Interventions

APL-9 DRUG

Complement (C3) Inhibitor

180 mg APL-9 IV plus SOC

Vehicle Control OTHER

Normal saline of equal volume to active arm

Isotonic saline plus SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age at time of informed consent
• Diagnosis of active SARS CoV 2 infection using viral RNA or viral antigen within 7 days of screening
• Respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation with PaO2/FiO2 ratio \>100 mm Hg. Respiratory failure cannot be fully explained by cardiac failure or fluid overload.

You may not qualify if:

• Treatment with immune checkpoint inhibitors, or other immunomodulators within 3 months prior to study enrollment (however, treatment with convalescent plasma, steroids, IL-6 inhibitors, and antiviral agents is NOT excluded)
• Active bacterial, fungal, or parasitic infection
• History of neuromuscular degenerative disease (eg, amyotrophic lateral sclerosis, Duchenne muscular dystrophy, or multiple sclerosis)
• Current participation in an interventional clincial trial
• Subjects who have, at screening, been on mechanical ventilation for \>7 days Have evidence of kidney and liver failure at screening
• Have a hereditary complement deficiency
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Apellis Pharmaceuticals, Inc.: lead

Study Sites (24)

University of California at San Francisco - Fresno

Fresno, California, 93701, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Baptist Medical Center Beaches

Jacksonville Beach, Florida, 32250, United States

Location

Westchester General Hospital

Miami, Florida, 40241, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Lutheran Health Physicians

Fort Wayne, Indiana, 46804, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Norton Women's and Children's Hospital

Louisville, Kentucky, 40207, United States

Location

Norton Audobon Hospital

Louisville, Kentucky, 40217, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

Rutgers University - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Texas A&M College of Medicine - Scott and White

Temple, Texas, 76508, United States

Location

Hospital Angelina Caron

Campina Grande do Sul, Paraná, 83430-000, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 91530-001, Brazil

Location

UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP

Botucatu, São Paulo, 18618-686, Brazil

Location

Hospital Estadual Mario Covas

Santo André, São Paulo, 09190-615, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP

São Bernardo do Campo, São Paulo, 0917-090, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, 01323-020, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-120, Brazil

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Respiration Disorders

Results Point of Contact

• Title: Apellis Clinical Trial Information Line
• Organization: Apellis Pharmaceuticals, Inc

clinicaltrials@apellis.com

1-833-284-6361

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: May 28, 2020
• Primary Completion: February 13, 2021
• Study Completion: February 13, 2021
• Last Updated: March 23, 2022
• Results First Posted: March 23, 2022

Record last verified: 2022-03

Locations

US (16); BR (8)