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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
Pivotal Trial

Summary

This trial is testing lenzilumab, a medication that blocks a protein causing severe inflammation, in hospitalized COVID-19 patients with severe pneumonia. The goal is to see if it helps these patients recover faster and avoid needing ventilators. Lenzilumab has been used in high-risk COVID-19 patients with severe pneumonia, showing faster improvement in clinical outcomes and oxygenation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Percentage of Participants Experiencing Adverse Events
Percentage of Participants Experiencing Serious Adverse Events
Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Lenzilumab
Not yet FDA approved
Standard of Care
2017
Completed Phase 4
~4420

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Who is running the clinical trial?

Humanigen, Inc.Lead Sponsor
9 Previous Clinical Trials
567 Total Patients Enrolled
Cameron Durrant, MDStudy DirectorHumanigen, Inc.
~96 spots leftby Oct 2025
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