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Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With 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. Identifier: NCT04351152
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):
Humanigen, Inc.

Brief Summary:
The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery in hospitalized subjects with severe or critical COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 (COVID-19) Pneumonia Biological: Lenzilumab Drug: Standard of Care Phase 3

Detailed Description:

In COVID-19, high levels of granulocyte macrophage-colony stimulating factor (GM-CSF) and inflammatory myeloid cells correlate with disease severity, cytokine storm, and respiratory failure. This phase 3 randomized, double-blind, multicenter, placebo-controlled clinical trial will evaluate the impact of lenzilumab (anti-human GM-CSF monoclonal antibody) on time to recovery in hospitalized patients with severe or critical COVID-19 pneumonia.

Approximately 300 patients will be randomized to receive lenzilumab + SOC vs. SOC in a 1:1 ratio. A pre-specified interim futility analysis is planned for the DSMB.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Lenzilumab Arm
Participants will receive IV infusion of lenzilumab upon randomization at a pre-specified dosing interval and continued administration of standard of care
Biological: Lenzilumab
Administered as an intravenous (IV) infusion
Other Name: Humaneered® anti-human GM-CSF monoclonal Antibody

Drug: Standard of Care
Standard of care therapy per local written policies or guidelines

Placebo Comparator: Placebo Arm
Participants will receive IV infusion of saline upon randomization matched to lenzilumab at same pre-specified dosing interval and continued administration of standard of care
Drug: Standard of Care
Standard of care therapy per local written policies or guidelines

Primary Outcome Measures :
  1. Time to Recovery [ Time Frame: Up to 28 days ]
    Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).

Secondary Outcome Measures :
  1. Incidence of Invasive Mechanical Ventilation and/or Death [ Time Frame: Up to 28 days ]
  2. Incidence of severe acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 28 days ]
  3. Duration of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 28 days ]
  4. Ventilator-free Days [ Time Frame: Up to 60 days ]
  5. Duration of Hospitalization [ Time Frame: Up to 28 days ]
  6. Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale [ Time Frame: Up to Day 28 ]
  7. Time to Death [ Time Frame: Up to Day 28 ]
  8. Number of Subjects Alive and Off Oxygen [ Time Frame: Up to 60 days ]
  9. Percentage of Participants Experiencing Adverse Events [ Time Frame: Up to 60 days ]
    Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  10. Percentage of Participants Experiencing Serious Adverse Events [ Time Frame: Up to 60 days ]
    Using the NCI CTCAE version 5.0

  11. Proportion of Subjects Discharged from Hospital [ Time Frame: Up to Day 60 ]
  12. All-cause Mortality and Proportion of Subjects Alive [ Time Frame: Day 28 and Day 60 ]
  13. Time to improvement in oxygenation for > 48 hours [ Time Frame: Up to Day 28 ]
  14. Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device) [ Time Frame: Up to Day 28 ]
  15. Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours [ Time Frame: Up to Day 28 ]
    NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)

  16. Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale [ Time Frame: Up to Day 28 ]
  17. Duration of Time on Low-flow or High-flow Supplemental Oxygen [ Time Frame: Up to Day 28 ]

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:

  • Adults 18 years of age or older who are capable of providing informed consent or have a proxy capable of giving consent for them
  • Virologic confirmation of SARS-CoV-2 infection via any FDA authorized diagnostic test for SARS-CoV-2
  • Pneumonia diagnosed by Chest X-ray or Computed Tomography revealing infiltrates consistent with pneumonia
  • SpO2 ≤ 94% on room air and/or require supplemental oxygen (including high-flow oxygen support or NPPV)
  • Hospitalized, not requiring invasive mechanical ventilation during this hospitalization
  • Have not participated in other clinical trial for COVID-19 using an immunomodulatory monoclonal antibody or kinase inhibitor (use of remdesivir, corticosteroids, convalescent plasma, hydroxychloroquine or chloroquine is permitted)
  • Females of childbearing potential must have a negative serum or urine pregnancy test

Exclusion Criteria:

  • Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation prior to randomization
  • Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
  • Known active tuberculosis (TB), history of incompletely treated TB or suspected or known extrapulmonary TB
  • Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIV infection
  • History of pulmonary alveolar proteinosis (PAP)
  • Women of childbearing potential who are pregnant or breastfeeding
  • Known hypersensitivity to lenzilumab or any of its components
  • Use of any FDA approved anti-IL-6 (e.g., tocilizumab, sarilumab, sitlukimab), anti-IL-1 (e.g., anakinra, canakinumab) or kinase inhibitor (e.g., baracitinib, ibrutinib, acalabrutinib) therapy to treat COVID-19 within 8 weeks prior to randomization
  • Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization
  • Expected survival < 24h in the opinion of the investigator
  • Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study

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): NCT04351152

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Contact: Omar Ahmed, PharmD 201-509-0713
Contact: CTI Clinical Trial & Consulting Services (CRO) 513-598-9290

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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
University of Southern California (USC) Medical Center Recruiting
Los Angeles, California, United States, 90033
USC - Los Angeles County Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: M Center         
United States, Florida
Baptist Medical Center Recruiting
Jacksonville, Florida, United States, 32207
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32216
AdventHealth Orlando Recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
St. Elizabeth Healthcare Recruiting
Edgewood, Kentucky, United States, 41017
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Saint Barnabas Medical Center Recruiting
Livingston, New Jersey, United States, 07039
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
United States, Texas
St. David's Healthcare Recruiting
Austin, Texas, United States, 78705
St. David's North Austin Medical Center Recruiting
Austin, Texas, United States, 78758
Texas Health Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Humanigen, Inc.
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Study Director: Cameron Durrant, MD Humanigen, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Humanigen, Inc. Identifier: NCT04351152    
Other Study ID Numbers: HGEN003-06
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Humanigen, Inc.:
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF)
GM-CSF monoclonal antibody
Cytokine Release Syndrome (CRS)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Additional relevant MeSH terms:
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Coronavirus Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs