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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04402060
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : September 1, 2021
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
COVID Covid-19 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Ards Acute Respiratory Distress Syndrome Drug: APL-9 Other: Vehicle Control Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 28, 2020
Actual Primary Completion Date : February 19, 2021
Actual Study Completion Date : February 19, 2021

Arm Intervention/treatment
Experimental: 180 mg APL-9 IV plus SOC Drug: APL-9
Complement (C3) Inhibitor

Placebo Comparator: Isotonic saline Other: Vehicle Control
Normal saline of equal volume to active arm

Primary Outcome Measures :
  1. Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events. [ Time Frame: Day 1 through Day 51 ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Day 1 through Day 21 ]
  2. Any cause of mortality [ Time Frame: Day 1 through day 58 ]
  3. Sequential Organ Failure Assessment [ Time Frame: Day 1 through day 21 ]
    The minimum value is 0 and maximum value is 24. The higher a score the worse the outcome.

  4. Total duration of mechanical ventilation and/or oxygen therapy [ Time Frame: Day 1 through day 21 ]
  5. Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04402060

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Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc. Identifier: NCT04402060    
Other Study ID Numbers: APL9-COV-201
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury