NCT04351152

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (actual)
• Sponsor: Humanigen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In COVID-19, high levels of granulocyte macrophage-colony stimulating factor (GM-CSF) and inflammatory myeloid cells correlate with disease severity, cytokine storm, and respiratory failure. The mortality rate for hospitalized COVID-19 patients remains unacceptably high, particularly in patients who progress to invasive mechanical ventilation (IMV). This randomized, double-blind, multicenter, placebo-controlled pivotal phase 3 trial will evaluate the impact of lenzilumab (anti-human GM-CSF monoclonal antibody) on ventilator-free survival in hospitalized, hypoxic patients with COVID-19. The study is also designed to evaluate other key endpoints, including ventilator-free days, duration of ICU stay, incidence of IMV, ECMO and/or death, time to death, all-cause mortality and time to recovery. Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio.

Conditions

• Coronavirus Disease 2019 (COVID-19) Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	Lenzilumab	Administered as an intravenous (IV) infusion
DRUG	Standard of Care	Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies

Timeline

• Start date: 2020-05-05
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2020-04-17
• Last updated: 2021-03-03

Locations

29 sites across 2 countries: United States, Brazil

Regulatory

• FDA-regulated drug study