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Monoclonal Antibodies

Lenzilumab Arm for Coronavirus Pneumonia

Phase 3
Waitlist Available
Research Sponsored by Humanigen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 60
Awards & highlights

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.

Eligible Conditions
  • Coronavirus Pneumonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ventilator-free Survival
Secondary outcome measures
All-cause Mortality
Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale
Duration of Hospitalization
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lenzilumab ArmExperimental Treatment2 Interventions
Participants will receive IV infusion of lenzilumab upon randomization at a pre-specified dosing interval and continued administration of standard of care
Group II: Placebo ArmPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Lenzilumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Humanigen, Inc.Lead Sponsor
9 Previous Clinical Trials
567 Total Patients Enrolled
Cameron Durrant, MDStudy DirectorHumanigen, Inc.
~101 spots leftby Jul 2025