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A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

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Trial Profile

A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Vilobelimab (Primary) ; Anticoagulants; Baricitinib; Dexamethasone; Immunomodulators; Tocilizumab
  • Indications COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms PANAMO
  • Sponsors InflaRx

Most Recent Events

  • 15 Jan 2025 According to an InflaRx media release, company has announced that the European Commission (EC) has granted marketing authorization under exceptional circumstances for GOHIBIC (vilobelimab) for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome. The EU approval of GOHIBIC is supported by the previously announced results of the multicenter Phase 3 PANAMO trial. Under the terms of GOHIBIC (vilobelimab)s approval in the EC, InflaRx will provide annual update
  • 15 Nov 2024 According to an InflaRx media release, company anticipates approval of vilobelimab for COVID-19 pneumonia in European Union (IV) in early 2025.
  • 15 Nov 2024 According to an InflaRx media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC, under exceptional circumstances for patients with SARS-CoV-2-induced ARDS receiving systemic corticosteroids and invasive mechanical ventilation The Company expects the European Commission to adopt the positive opinion and issue a marketing authorization within 67 days.

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