Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Summary

Primary objectives Part 1: \- To evaluate the safety and tolerability of COR-101 compared to placebo Secondary objectives Part 1: * To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 * To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

Timeline

Start

2021-04-21

Primary completion

2022-10-30

Completion

2022-10-30

Publications

• Marconato M, Hackenbruch C, Jager S, Gopel S, capital KA, Cyrillicirieieva T, Gavrylov A, Fricke H, Hust M, Dubel S, Dings C, Lehr T, Cuevas M, Bitzer M, Klein C, Schwab M, Wirtz H, Schneider J, Bitter T, Frenzel A, Dhaen MA, Herrmann A, Jung G, Walz JS, Salih HR, Heitmann JS. Phase I Study Evaluating a Monoclonal Fc-Silenced SARS-CoV-2 Antibody in Patients With Moderate-to-Severe COVID-19. Clin Ther. 2026 Mar;48(3):232-239. doi: 10.1016/j.clinthera.2026.01.004. Epub 2026 Feb 7.
• 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

Indications