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

NCT04351152 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2021-03-03

No results posted yet for this 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.

Conditions

  • Coronavirus Disease 2019 (COVID-19) Pneumonia

Interventions

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

Sponsors & Collaborators

  • Humanigen, Inc.

    lead INDUSTRY

Principal Investigators

  • Cameron Durrant, MD · Humanigen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-05
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States
  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351152 on ClinicalTrials.gov