hzVSF-v13

hzVSF-v13_0007 trial is a multicenter phase 2 randomized control trial to evaluate the efficacy and safety of a novel anti-vimentin monoclonal antibody for moderate to severe COVID-19 patients

Information

This study aims to evaluate the efficacy and safety of a novel anti-vimentin monoclonal antibody for moderate to severe COVID-19 patients. Indonesia managed to recruit 64 subjects in three sites (Persahabatan Hospital, Pasar Minggu District Hospital, and Pertamina Hospital) on December 2020 - August 2021. This trial was sponsored by ImmuneMed, Inc in collaboration with PT Prodia Diacro Laboratories. The result this phase II trial had been published in Journal of Clinical Medicine (https://www.mdpi.com/2077-0383/11/11/2961)

  • Immunemed
  • Prodia Diacro Laboratories

Type of Study

Stakeholders Involved

COVID-19 Clinical Trial

Background

Coronavirus disease 2019 (COVID-19) can progress to moderate and severe illness characterized by excessive inflammatory responses and immune dysregulation, leading to respiratory failure and increased mortality. Vimentin, a host cell protein involved in viral entry and inflammatory signaling, has emerged as a potential therapeutic target in COVID-19 management. The hzVSF-v13_0007 trial was designed to evaluate a novel anti-vimentin monoclonal antibody as an immunomodulatory approach to reduce disease severity and improve clinical outcomes. Conducted during the early phase of the pandemic, this study aimed to generate clinical evidence on the efficacy and safety of targeting host-mediated inflammatory pathways in hospitalized patients with moderate to severe COVID-19.