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Phase II/III COMET-ICE trial of VIR 7831 in COVID-19 doses first patient.- Vir Biotechnology + GlaxoSmithKline
Vir Biotechnology and GlaxoSmithKline announced that the first patient was dosed last week in a phase II/III study with VIR 7831 (also known as GSK 4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enrol approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR 7831, as a single-dose monoclonal antibody, can prevent hospitalisation due to COVID-19. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021. Last week's initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses. The COMET-ICE multi-centre, double-blind, placebo-controlled phase II/III study investigating VIR 7831 in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease comprises two parts. The first part (the Lead-In phase) will serve as the first-in-human assessment. The Lead-In phase will assess the safety and tolerability of a single intravenous (IV) infusion of VIR 7831 or placebo over a 14-day period in non-hospitalised patients. It aims to recruit 20 patients across the United States. Following this initial safety assessment, the second part (the Expansion phase) will progress with the aim of reducing the need for hospitalisation. The Expansion phase will assess the safety and efficacy of a single IV infusion of VIR 7831 or placebo in approximately 1,300 non-hospitalised participants globally. The primary efficacy endpoint is the proportion of patients with mild or moderate COVID-19 who worsen, as defined by the need for hospitalisation or death, within 29 days of randomisation. The COMET clinical development programme for VIR 7831 also includes two additional planned trials—one for the treatment of severely ill hospitalised patients, and another for the prophylaxis of symptomatic infection.
Condition: Coronavirus/COVID-19 Infection
Type: drug