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Trial record 1 of 1 for:    APL-9
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A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04402060
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : June 9, 2020
Sponsor:
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)
Estimated Enrollment : 66 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
Estimated Study Start Date : May 26, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


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 21 ]

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 51 ]
  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 [ Time Frame: Day 1 through day 21 ]
  5. Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]


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

Inclusion Criteria:

  • Be at least 18 years of age at time of informed consent
  • Diagnosed with COVID-19 within 7 days of screening
  • Have respiratory failure requiring oxygen supplementation or either invasive or noninvasive mechanical ventilation
  • Have worsening of respiratory symptoms within the past week
  • Have bilateral opacities present on a chest radiograph or computed tomographic scan, and 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 (treatment with steroids, interleukin-6 inhibitors and antiviral agents are allowed)
  • Treatment with convalescent plasma for COVID-19 within 3 months of baseline
  • Current participation in an interventional clinical trial
  • Have 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 ClinicalTrials.gov identifier (NCT number): NCT04402060


Contacts
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Contact: Apellis Clinical Trial Information Line 1-833-284-6361 clinicaltrials@apellis.com

Locations
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United States, Florida
Westchester General Hospital Recruiting
Miami, Florida, United States, 40241
United States, Kentucky
Norton Women's and Children's Hospital Recruiting
Louisville, Kentucky, United States, 40207
Audobon Hospital Recruiting
Louisville, Kentucky, United States, 40217
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.
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Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04402060    
Other Study ID Numbers: APL9-COV-201
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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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, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Lung Injury
Respiratory Tract Infections