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A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection

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Trial Profile

A Phase 2/3, Randomized, Parallel-group, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of CT-P59 in Combination With Standard of Care in Outpatients With SARS-CoV-2 Infection

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Jul 2022

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At a glance

  • Drugs Regdanvimab (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Celltrion

Most Recent Events

  • 07 Dec 2021 According to a Celltrion Healthcare Australia Pty Ltd media release, the company announced that the Therapeutic Goods Administration (TGA) granted provisional approval for the use of regdanvimab (regkirona) in adult patients with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. TGAs decision is based o data from this study.
  • 18 Nov 2021 Status changed from recruiting to completed.
  • 11 Nov 2021 According to a Celltrion media release, European Medicine's Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59) for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

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