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

NCT ID: NCT04402060

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-02-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

180 mg APL-9 IV plus SOC

Group Type: EXPERIMENTAL

APL-9

Intervention Type: DRUG

Complement (C3) Inhibitor

Isotonic saline plus SOC

Group Type: PLACEBO_COMPARATOR

Vehicle Control

Intervention Type: OTHER

Normal saline of equal volume to active arm

Interventions

APL-9

Complement (C3) Inhibitor

Intervention Type: DRUG

Vehicle Control

Normal saline of equal volume to active arm

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apellis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California at San Francisco - Fresno

Fresno, California, United States

California Pacific Medical Center

San Francisco, California, United States

Baptist Medical Center Beaches

Jacksonville Beach, Florida, United States

Westchester General Hospital

Miami, Florida, United States

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Lutheran Health Physicians

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Norton Women's and Children's Hospital

Louisville, Kentucky, United States

Norton Audobon Hospital

Louisville, Kentucky, United States

Cambridge Medical Trials

Alexandria, Louisiana, United States

Ascension Providence Hospital

Southfield, Michigan, United States

Rutgers University - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

University at Buffalo

Buffalo, New York, United States

Columbia University

New York, New York, United States

Texas A&M College of Medicine - Scott and White

Temple, Texas, United States

Hospital Angelina Caron

Campina Grande do Sul, Paraná, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

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

Botucatu, São Paulo, Brazil

Hospital Estadual Mario Covas

Santo André, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clinicos LTDA EPP

São Bernardo do Campo, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Countries

United States; Brazil

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

APL9-COV-201

Identifier Type: -

Identifier Source: org_study_id