Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
NCT ID: NCT04351152
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
520 participants
INTERVENTIONAL
2020-05-05
2021-03-31
Brief Summary
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Detailed Description
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Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lenzilumab Arm
Participants will receive IV infusion of lenzilumab upon randomization at a pre-specified dosing interval and continued administration of standard of care
Lenzilumab
Administered as an intravenous (IV) infusion
Standard of Care
Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies
Placebo Arm
Participants will receive IV infusion of preservative-free 0.9% sodium chloride solution upon randomization matched to lenzilumab at same pre-specified dosing interval and continued administration of standard of care
Standard of Care
Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies
Interventions
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Lenzilumab
Administered as an intravenous (IV) infusion
Standard of Care
Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
* 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
* 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 authorized anti-IL-6 (e.g., tocilizumab, sarilumab, sitlukimab), anti-IL-1 (e.g., anakinra, canakinumab), kinase inhibitor (e.g., baracitinib, ibrutinib, acalabrutinib), or neutralizing monoclonal antibody (e.g. bamlanivimab or casirivimab/imdevimab) 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 \< 48h 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
18 Years
ALL
No
Sponsors
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Humanigen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cameron Durrant, MD
Role: STUDY_DIRECTOR
Humanigen, Inc.
Locations
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Mayo Clinic
Phoenix, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of Southern California (USC) Medical Center
Los Angeles, California, United States
USC - Los Angeles County Medical Center
Los Angeles, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Mercy Medical Center
Rockville Centre, New York, United States
Atrium Health
Charlotte, North Carolina, United States
St. David's Healthcare
Austin, Texas, United States
St. David's North Austin Medical Center
Austin, Texas, United States
Texas Health
Dallas, Texas, United States
Hospital Vera Cruz
Belo Horizonte, Minas Gerais, Brazil
CPCLIN - Centro de Pesquisas Clínicas de Natal
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Sociedade Literaria e Caritativa Santo Agostinho
Criciúma, Santa Catarina, Brazil
Hospital Dia do Pulmão
Blumenau, São Paulo, Brazil
Hospital Guilherme Alvaro
Santos, São Paulo, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA-EPP
São Bernardo do Campo, São Paulo, Brazil
Clinica de Alergia Martti Antila S/S LTDA
Sorocaba, São Paulo, Brazil
Escola Paulista de Medicina (UNIFESP)
São Paulo, , Brazil
Hospital Heliópolis
São Paulo, , Brazil
Hospital São Luiz do Jabaquara/IDOR
São Paulo, , Brazil
Countries
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References
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Temesgen Z, Kelley CF, Cerasoli F, Kilcoyne A, Chappell D, Durrant C, Ahmed O, Chappell G, Catterson V, Polk C, Badley A, Marconi VC; LIVE-AIR Study Group. C reactive protein utilisation, a biomarker for early COVID-19 treatment, improves lenzilumab efficacy: results from the randomised phase 3 'LIVE-AIR' trial. Thorax. 2023 Jun;78(6):606-616. doi: 10.1136/thoraxjnl-2022-218744. Epub 2022 Jul 6.
Temesgen Z, Burger CD, Baker J, Polk C, Libertin CR, Kelley CF, Marconi VC, Orenstein R, Catterson VM, Aronstein WS, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD; LIVE-AIR Study Group. Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Mar;10(3):237-246. doi: 10.1016/S2213-2600(21)00494-X. Epub 2021 Dec 1.
Temesgen Z, Burger CD, Baker J, Polk C, Libertin C, Kelley C, Marconi VC, Orenstein R, Durrant C, Chappell D, Ahmed O, Chappell G, Badley AD. LENZILUMAB EFFICACY AND SAFETY IN NEWLY HOSPITALIZED COVID-19 SUBJECTS: RESULTS FROM THE LIVE-AIR PHASE 3 RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL. medRxiv [Preprint]. 2021 May 5:2021.05.01.21256470. doi: 10.1101/2021.05.01.21256470.
Aroldi A, Chiarle R, Gambacorti-Passerini C. Clinical Benefit of Lenzilumab in Cases of Coronavirus Disease 2019. Mayo Clin Proc. 2021 Mar;96(3):817. doi: 10.1016/j.mayocp.2020.12.030. Epub 2021 Jan 11. No abstract available.
Temesgen Z, Assi M, Shweta FNU, Vergidis P, Rizza SA, Bauer PR, Pickering BW, Razonable RR, Libertin CR, Burger CD, Orenstein R, Vargas HE, Palraj R, Dababneh AS, Chappell G, Chappell D, Ahmed O, Sakemura R, Durrant C, Kenderian SS, Badley AD. GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study. Mayo Clin Proc. 2020 Nov;95(11):2382-2394. doi: 10.1016/j.mayocp.2020.08.038. Epub 2020 Sep 3.
Other Identifiers
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HGEN003-06
Identifier Type: -
Identifier Source: org_study_id
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