A Study to Evaluate Effectiveness and Safety of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia (Enrolling by Invitation Only)

Overview

About this study

The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Currently hosptialized at a Mayo Clinic hospital.
  • Adults ≥ 18 years of age who are capable of providing informed consent or have a proxy capable of giving consent for them.
  • Virologic confirmation of Sars-CoV-2 infection by q PCR and confirmed COVID-19 diagnosis.
  • Pneumonia diagnosed by Chest Xray, Computed Tomography or Magnetic Resonance imaging revealing infiltrates consistent with pneumonia and not yet developed ARDS.
  • Have not participated in other clinical trial for COVID-19 (use of remdesivir, convalescent plasma, hydroxychloroquine or chloroquine is permitted).
  • Females of childbearing potential must have a negative serum or urine pregnancy test .

Exclusion Criteria:

  • Confirmed diagnosis of ARDS.
  • Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
  • Known medical history of tuberculosis or a risk for tuberculosis exposure.
  • Known history of hepatitis A, hepatitis B, hepatitis C or HIV infection.
  • History of pulmonary alveolar proteinosis (PAP).
  • Requiring invasive mechanical ventilation upon hospitalization prior to randomization.
  • Women of childbearing potential who are pregnant or breastfeeding.
  • Known hypersensitivity to lenzilumab or any of its components.
  • Use of anti-IL-6 therapy or any other potent immunomodulatory or immunosuppressive therapy or live vaccine within 8 weeks of randomization (corticosteroid use is permitted).
  • Use of GM-CSF agents (e.g., sargramostim) within prior 2 months of randomization.
  • Expected survival < 24 hours in the opinion of the investigator.
  • Patient > 85 years of age.
  • Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Charles Burger, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Orenstein, D.O.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Robert Orenstein D.O.

(480) 342-0115

Rochester, Minn.

Mayo Clinic principal investigator

Zelalem Temesgen, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Department of Medicine - Clinical Trials Unit

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20486775

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