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
Price :
$35
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At a glance
- Drugs Regdanvimab (Primary)
- Indications COVID 2019 infections
- Focus Registrational; Therapeutic Use
- Sponsors Celltrion
- 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.