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

• ClinicalTrials.gov Identifier: NCT04402060
• Recruitment Status: Recruiting
• First Posted: May 26, 2020
• Last Update Posted: December 19, 2020
• Sponsor: Apellis Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Apellis Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: May 22, 2020
• First Posted Date: May 26, 2020
• Last Update Posted Date: December 19, 2020
• Actual Study Start Date: May 28, 2020
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 13, 2020): Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events. [ Time Frame: Day 1 through Day 51 ]
• Original Primary Outcome Measures (submitted: May 22, 2020): Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events. [ Time Frame: Day 1 through Day 21 ]

Current Secondary Outcome Measures (submitted: December 16, 2020)

• Hospital length of stay [ Time Frame: Day 1 through Day 21 ]
• Any cause of mortality [ Time Frame: Day 1 through day 58 ]
• 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.
• Total duration of mechanical ventilation and/or oxygen therapy [ Time Frame: Day 1 through day 21 ]
• Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]

Original Secondary Outcome Measures (submitted: May 22, 2020)

• Hospital length of stay [ Time Frame: Day 1 through Day 21 ]
• Any cause of mortality [ Time Frame: Day 1 through day 51 ]
• SOFA score [ Time Frame: Day 1 through day 21 ]
• Total duration of mechanical ventilation [ Time Frame: Day 1 through day 21 ]
• Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: APL-9
  Complement (C3) Inhibitor
• Other: Vehicle Control
  Normal saline of equal volume to active arm

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 22, 2020): 66
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Brazil, United States

Administrative Information

• NCT Number: NCT04402060
• Other Study ID Numbers: APL9-COV-201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Apellis Pharmaceuticals, Inc.
• Study Sponsor: Apellis Pharmaceuticals, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Apellis Pharmaceuticals, Inc.
• Verification Date: December 2020