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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

Study 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19
2020. "Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04351152.
All > Covid
~106 spots leftby Apr 2025
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