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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402060
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 26, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: May 22, 2020)
Cumulative incidence of treatment-emergent serious adverse events and treatment-emergent adverse events. [ Time Frame: Day 1 through Day 21 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 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 [ Time Frame: Day 1 through day 21 ]
  • Total duration of oxygen therapy [ Time Frame: Day 1 through day 21 ]
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID
  • Covid-19
  • Coronavirus
  • Coronavirus Infection
  • Severe Acute Respiratory Syndrome
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Sars-CoV2
  • Ards
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: APL-9
    Complement (C3) Inhibitor
  • Other: Vehicle Control
    Normal saline of equal volume to active arm
Study Arms  ICMJE
  • Experimental: 180 mg APL-9 IV plus SOC
    Intervention: Drug: APL-9
  • Placebo Comparator: Isotonic saline
    Intervention: Other: Vehicle Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Apellis Clinical Trial Information Line 1-833-284-6361 clinicaltrials@apellis.com
Listed Location Countries  ICMJE Brazil,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04402060
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Apellis Pharmaceuticals, Inc.
Study Sponsor  ICMJE Apellis Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Apellis Pharmaceuticals, Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP