Study of Efficacy and Safety of MAS825 in Patients With COVID-19

Summary

This clinical study was designed to assess the efficacy and safety of MAS825 for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) infected patients with coronavirus disease 2019 (COVID-19) pneumonia and impaired respiratory function.

Timeline

Start

2020-06-11

Primary completion

2021-01-06

Completion

2021-04-21

Outcome

Missed primary endpoint

paper MAS825 + SoC did not improve APACHE II score in hospitalized patients with severe COVID-19 pneumonia PMID 37338154 ↗

registry analysis (superiority test); MAS825 + SoC vs Placebo + SoC; p = 0.33 NCT04382651 ↗

Publications

• Hakim AD, Awili M, O'Neal HR, Siddiqi O, Jaffrani N, Lee R, Overcash JS, Chauffe A, Hammond TC, Patel B, Waters M, Criner GJ, Pachori A, Junge G, Levitch R, Watts J, Koo P, Sengupta T, Yu L, Kiffe M, Pinck A, Stein RR, Bendrick-Peart J, Jenkins J, Rowlands M, Waldron-Lynch F, Matthews J. Efficacy and safety of MAS825 (anti-IL-1beta/IL-18) in COVID-19 patients with pneumonia and impaired respiratory function. Clin Exp Immunol. 2023 Oct 13;213(3):265-275. doi: 10.1093/cei/uxad065.
• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MAS825	Monoclonal antibody	10 mg/kg	Intravenous

Indications