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Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia

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: NCT04351152
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : May 27, 2020
Sponsor:
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 (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with 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:
Most deaths in COVID-19 patients result from respiratory distress, which appears to be driven in large part by a CRS mediated hyper-immune reaction ('cytokine storm') that may occur even in patients who appear to be resolving their infection by viral titers. In addition, GM-CSF+T cells are highly correlated with severity and ICU admission in the setting of COVID-19. For this reason, it is critical to intervene prior to the initiation of CRS and severe respiratory distress in patients at high risk of progression. This phase 3 randomized, multicenter, placebo-controlled clinical trial will evaluate the impact of GM-CSF neutralization with lenzilumab on incidence of respiratory failure and/or death in patients with COVID-19 pneumonia upon hospitalization. 238 patients will be randomized to receive lenzilumab + SOC vs. SOC in a 1:1 ratio. An interim analysis is planned for DSMB to assess safety & efficacy data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With 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. Incidence of invasive mechanical ventilation (IMV) and/or Mortality [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Incidence of acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 28 days ]
    Acute respiratory distress syndrome defined as new or worsening respiratory symptoms with PaO2/FiO2 ≤ 300 mmHg or SpO2/FiO2 ≤ 315, chest imaging (radiograph, CT scan, or lung ultrasound) revealing bilateral opacities and pulmonary infiltrates not fully explained by fluid overload or cardiac failure

  2. Duration of Hospitalization [ 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. Incidence of Non-invasive Ventilation [ Time Frame: Up to 28 days ]
  6. Proportion of Participants Alive and Off Oxygen [ Time Frame: Up to 60 days ]
  7. 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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults > 18 years of age who are capable of providing informed consent or have a proxy capable of giving consent for them
  • Virologic confirmation of Sars-CoV-2 infection by q PCR and confirmed COVID-19 diagnosis
  • Pneumonia diagnosed by Chest Xray, Computed Tomography or Magnetic Resonance imaging revealing infiltrates consistent with pneumonia and not yet developed ARDS
  • Have not participated in other clinical trial for COVID-19 (use of remdesivir, hydroxychloroquine or chloroquine is permitted)
  • Females of childbearing potential must have a negative serum or urine pregnancy test

Exclusion Criteria:

  • Confirmed diagnosis of ARDS
  • Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline
  • Known medical history of tuberculosis or a risk for tuberculosis exposure
  • Known history of hepatitis A, hepatitis B, hepatitis C or HIV infection
  • History of pulmonary alveolar proteinosis (PAP)
  • Requiring invasive mechanical ventilation upon hospitalization prior to randomization
  • Women of childbearing potential who are pregnant or breastfeeding
  • Known hypersensitivity to lenzilumab or any of its components
  • Use of anti-IL-6 therapy or any other potent immunomodulatory or immunosuppressive therapy or live vaccine within 8 weeks of randomization (corticosteroid use is permitted)
  • Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization
  • Expected survival < 24h in the opinion of the investigator
  • Patient > 85 years of age
  • 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 ClinicalTrials.gov identifier (NCT number): NCT04351152


Contacts
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Contact: Omar Ahmed, PharmD 201-509-0713 oahmed@humanigen.com
Contact: CTI Clinical Trial & Consulting Services (CRO) 513-598-9290 HumanigenPhase3@ctifacts.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, California
Stanford University Not yet recruiting
Redwood City, California, United States, 94063
United States, Florida
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, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Recruiting
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
United States, Texas
Texas Health Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Humanigen, Inc.
Investigators
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Study Director: Cameron Durrant, MD Humanigen, Inc.
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Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT04351152    
Other Study ID Numbers: HGEN003-06
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 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
Pneumonia
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