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

Inclusion Criteria:

• Adults 18 years of age or older who are capable of providing informed consent or havea proxy capable of giving consent for them
• Virologic confirmation of SARS-CoV-2 infection via any FDA authorized diagnostic testfor SARS-CoV-2
• Pneumonia diagnosed by Chest X-ray or Computed Tomography revealing infiltratesconsistent with pneumonia
• SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or requirehigh-flow oxygen support or NIPPV
• Hospitalized, not requiring invasive mechanical ventilation during thishospitalization
• Have not participated in other clinical trial for COVID-19 using an immunomodulatorymonoclonal 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 priorto randomization
• Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal orviral infections at screening/baseline
• Known active tuberculosis (TB), history of incompletely treated TB or suspected orknown extrapulmonary TB
• Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIVinfection
• 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 orcasirivimab/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 withthe safety and efficacy of the study treatment or puts the patient at unacceptablyhigh risk from the study