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

A

Apellis Pharmaceuticals

Status and phase

Completed
Phase 2
Phase 1

Conditions

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

Treatments

Drug: APL-9
Other: Vehicle Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT04402060
APL9-COV-201

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

72 participants in 2 patient groups, including a placebo group

180 mg APL-9 IV plus SOC
Experimental group
Treatment:
Drug: APL-9
Isotonic saline plus SOC
Placebo Comparator group
Treatment:
Other: Vehicle Control

Trial documents
2

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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