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A phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV") or Extracorporeal Membrane Oxygenation ("ECMO")

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A phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients with COVID-19 pneumonia with need for invasive mechanical ventilation ("IMV") or Extracorporeal Membrane Oxygenation ("ECMO")

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2022

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors CytoDyn

    • Most Recent Events

    • 30 Mar 2022 According to a CytoDyn media release, the U.S. Food and Drug Administration (FDA) a full clinical hold on leronlimab its COVID-19 program in the United States. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved.
    • 30 Mar 2022 Status changed from planning to suspended, according to an CytoDyn media release.
    • 21 Dec 2021 According to a CytoDyn media release, the company has received a positive response from the USA Food and Drug Administration (FDA) to conduct this study.

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