Study of Tixagevimab/Cilgavimab and Regdanvimab Efficacy for Treatment of COVID-19

Summary

Study hypothesis: the viral neutralizing monoclonal antibodies Tiksagevimab/Cilgavimab and Regdanvimab have high neutralizing activity against SARS-CoV-2 coronavirus, including Omicron strain, and may be effective in treating patients with moderate to severe COVID-19. Description of the clinical study: Administration of monoclonal antibodies as antiviral therapy to patients with covid-19 and further Assesment of viral neutralizing monoclonal antibodies (Tiksagevimab/Cilgavimab and Regdanvimab) efficacy for treatment of new coronavirus infection (COVID-19) in adult patients. Participation of patients of both sexes aged 18 years or older with COVID-19 of moderate to severe course, hospitalized. Inclusion of 82 patients in the study: 38 in the tixagevimab/cilgavimab group (at a dose of 150+150 mg), 24 patients in the regdanvimab group (at a dose of 40 mg/kg body weight) and 20 patients in the tixagevimab/cilgavimab group (at a dose of 300+300 mg).

Timeline

Start

2022-08-18

Primary completion

2022-09-19

Completion

2023-11-01

Publications

• Fomina DS, Lebedkina MS, Iliukhina AA, Kovyrshina AV, Shelkov AY, Andreev SS, Chernov AA, Dolzhikova IV, Kruglova TS, Andrenova GV, Tukhvatulin AI, Shcheblyakov DV, Karaulov AV, Lysenko MA, Logunov DY, Gintsburg AL. Real-world clinical effectiveness of Tixagevimab/Cilgavimab and Regdanvimab monoclonal antibodies for COVID-19 treatment in Omicron variant-dominant period. Front Immunol. 2023 Oct 20;14:1259725. doi: 10.3389/fimmu.2023.1259725. eCollection 2023.

Drugs

Indications