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Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19. A Phase 2/3, Randomized, Open-label, Parallel Group, 2-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Added to Standard of Care, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS- CoV-2 Infection

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Trial Profile

Clinical Trial of the Use of Anakinra in Cytokine Storm Syndrome Secondary to Covid-19. A Phase 2/3, Randomized, Open-label, Parallel Group, 2-arm, Multicenter Study Investigating the Efficacy and Safety of Intravenous Administrations of Anakinra, an Interleukin-1(IL-1) Receptor Antagonist, Added to Standard of Care, Versus Standard of Care, in Reducing Hyper-inflammation and Respiratory Distress in Patients With SARS- CoV-2 Infection

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 10 Jul 2023

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At a glance

  • Drugs Anakinra (Primary) ; Anakinra (Primary) ; Azithromycin; Hydroxychloroquine; Lopinavir/ritonavir
  • Indications COVID 2019 infections; COVID-19 pneumonia; Cytokine release syndrome; Respiratory distress syndrome
  • Focus Therapeutic Use
  • Acronyms ANA-COVID-GEAS

Most Recent Events

  • 03 Jun 2023 Primary endpoint has not been met. (Treatment success, defined as number of patients not requiring mechanical ventilation to assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.), as per results presented at the 24th Annual Congress of the European League Against Rheumatism .
  • 03 Jun 2023 Results presented at the 24th Annual Congress of the European League Against Rheumatism
  • 27 May 2021 Status changed from recruiting to completed.

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