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A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia

Trial Profile

A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2020

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At a glance

  • Drugs Lenzilumab (Primary)
  • Indications Adult respiratory distress syndrome; COVID-19 pneumonia; Respiratory insufficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Humanigen
  • Most Recent Events

    • 06 Nov 2020 According to a Humanigen media release, CRADA between Humanigen and U.S. government provides for regulatory and other support to submit an EUA and BLA.
    • 06 Nov 2020 According to a Humanigen media release, the company intends to file for EUA in the first quarter of 2021 either following interim data at 75 percent or at study completion.Current enrollment stands at 300 patients.
    • 06 Nov 2020 According to a Humanigen media release, at the recommendation of the DSMB, the company plans to increase enrollment to achieve 402 events (approximately 515 patients).This increase in enrollment ensures an even higher probability of success in meeting the primary endpoint and maintains the power of the study at 90 %. The next interim analysis for efficacy is planned when the study reaches 75 percent events (302 events) which will require approximately 390 patients to be enrolled in the trial.
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