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A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection

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Trial Profile

A Phase 2/3, Randomized, Open-label, Parallel Group, 3-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Emapalumab, an Anti-interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS-CoV-2 Infection

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 14 Mar 2022

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At a glance

  • Drugs Anakinra (Primary) ; Emapalumab (Primary)
  • Indications COVID 2019 infections; Inflammation; Respiratory distress syndrome
  • Focus Therapeutic Use
  • Sponsors Swedish Orphan Biovitrum

    • Most Recent Events

    • 11 Dec 2020 Status changed from recruiting to discontinued. Reason the study was stopped:Standard of care evolved during the timeframe of the study and had critical impact onrecruitment.Early termination is not based on safety reasons but because of recruitment issues.Patients ongoing will be completed. Planned LPLV 25Jan2021.
    • 10 Aug 2020 Planned End Date changed from 1 Sep 2020 to 1 Dec 2020.
    • 10 Aug 2020 Planned primary completion date changed from 1 Jul 2020 to 1 Nov 2020.

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