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

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease 2019 (COVID-19) Pneumonia

In brief

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 improve ventilator-free survival in hospitalized subjects with severe or critical COVID-19 pneumonia.

Key facts

Study ID

NCT04351152

Run by

Humanigen, Inc.

People needed

520

Starts

2020-05-05

Expected to finish

2021-03-01

Last updated by the study team

2021-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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

You may not qualify if…

• 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 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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