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A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE).

Trial Profile

A Multi-Center, Adaptive, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE).

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 02 Jun 2020

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At a glance

  • Drugs Gimsilumab (Primary)
  • Indications Acute lung injury; Adult respiratory distress syndrome; COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms BREATHE
  • Sponsors Kinevant Sciences GmbH
  • Most Recent Events

    • 13 May 2020 According to a Roivant Sciences media release, the company recently amended the protocol to permit the use of investigational antivirals (e.g. remdesivir) during the study, as well as treatment with convalescent plasma prior to enrollment.
    • 13 May 2020 According to a Roivant Sciences media release, Independent Data Monitoring Committee unanimously recommends trial continuation after pre-specified safety assessment.
    • 13 May 2020 According to a Roivant Sciences media release, fifty-six patients have been enrolled in the study to date, and a total of 7 sites have been initiated in New York, Philadelphia, Detroit, New Orleans, Dallas, and Atlanta.
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