Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia

Trial Profile

A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 May 2020

At a glance

  • Drugs Lenzilumab (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections; Cytokine release syndrome; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Sponsors Humanigen
  • Most Recent Events

    • 06 May 2020 According to a Humanigen media release, first COVID-19 patient has been dosed in the study.
    • 30 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 15 Apr 2020 According to a Humanigen media release, if successful, this study may lead to a lenzilumab product approval for COVID-19.

Trial Overview

Purpose

This phase III randomized, controlled, multi-center study is designed to evaluate Lenzilumab for the prevention of respiratory failure/ARDS and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection in COVID-19 patients.The study enrollment will focus on adult, hospitalized patients with COVID-19 pneumonia and at high risk of progression to respiratory failure.
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.

Comments

According to a Humanigen media release, if successful, this study may lead to a lenzilumab product approval for COVID-19.

Primary Endpoints

Incidence of invasive mechanical ventilation (IMV) and/or Mortality

time_frame: Up to 28 days

Other Endpoints

Incidence of acute respiratory distress syndrome (ARDS)

description: 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
time_frame: Up to 28 days

Duration of Hospitalization

time_frame: Up to 28 days

Duration of Intensive Care Unit (ICU) Stay

time_frame: Up to 28 days

Ventilator-free Days

time_frame: Up to 60 days

Incidence of Non-invasive Ventilation

time_frame: Up to 28 days

Proportion of Participants Alive and Off Oxygen

time_frame: Up to 60 days

Percentage of Participants Experiencing Adverse Events

description: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
time_frame: Up to 60 days

Percentage of Participants Experiencing Serious Adverse Events

description: Using the NCI CTCAE version 5.0
time_frame: Up to 60 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Adult respiratory distress syndrome prevention -
COVID 2019 infections treatment -
Cytokine release syndrome treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 238

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient 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

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04351152 ClinicalTrials.gov: US National Institutes of Health
HGEN003-06 -

Organisations

  • Sponsors Humanigen
  • Affiliations Humanigen

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

    Actual : 30 Apr 2020

  • Primary Completion Dates

    Planned : 01 Sep 2020

  • End Dates

    Planned : 01 Sep 2020

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
LenzilumabPrimary Drug Intravenous Infusion

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 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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Cameron Durrant, MD Humanigen, Inc.
-
CTI Clinical Trial & Consulting Services (CRO)
513-598-9290 UnblindedHumanigenHGEN003-06@ctifacts.com
show details
-
Omar Ahmed, PharmD
201-509-0713
oahmed@humanigen.com
show details
, Humanigen, Inc.
-

Centres

Centre Name Location Trial Centre Country
-
-
-
AdventHealth Orlando Orlando, Florida USA
Atrium Health Charlotte, North Carolina USA
Dartmouth-Hitchcock Lebanon, New Hampshire USA
Emory University Atlanta, Georgia USA
Humanigen, Inc.
-
-
Humanigen, Inc.
-
-
Mayo Clinic Jacksonville, Florida USA
Mayo Clinic Phoenix, Arizona USA
Mayo Clinic Rochester, Minnesota USA
Stanford University Redwood City, California USA
Texas Health Dallas, Texas USA

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 28 May 2020
06 May 2020 Other trial event According to a Humanigen media release, first COVID-19 patient has been dosed in the study. Updated 11 May 2020
30 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 05 May 2020
20 Apr 2020 Other trial event New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT04351152) Updated 20 Apr 2020
15 Apr 2020 Other trial event According to a Humanigen media release, if successful, this study may lead to a lenzilumab product approval for COVID-19. Updated 21 Apr 2020
15 Apr 2020 Other trial event According to a Humanigen media release, the company is working with some of the top centers and clinicians in the US, alongside the contract research organization partner, CTI, to bring lenzilumab rapidly through this clinical study which, if successful, may reduce serious and potentially fatal outcomes in patients hospitalized with COVID-19 and at high risk of progression. Updated 21 Apr 2020
15 Apr 2020 Other trial event According to a Humanigen media release, the FDA has given permission to commence this Phase III study of lenzilumab in patients with COVID-19.The company will begin enrolling patients as soon as possible at several leading centers. Updated 21 Apr 2020
15 Apr 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 20 Apr 2020
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020
27 Mar 2020 Other trial event According to a Humanigen media release, the company has submitted an initial protocol synopsis to FDA for this trial. Updated 03 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Humanigen. Humanigen Submits Phase III Protocol Synopsis to FDA for Lenzilumab for Coronavirus Treatment. Media-Rel 2020;.

    Media Release
  3. Humanigen. FDA Approves Initiation of Humanigen's Phase III Study of Lenzilumab in COVID-19 Patients. Media-Rel 2020;.

    Media Release
  4. Humanigen. First Patient Dosed in FDA-Approved Phase III Lenzilumab Study for COVID-19. Media-Rel 2020;.

    Media Release
Back to top