Optimizing the use of vilobelimab for the treatment of COVID-19

ABSTRACT

Introduction

On 4 April 2023i4 April 2023, the United States Food and Drug Administration issued an emergency use authorization for the use of vilobelimab (Gohibic^TM) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.

Areas Covered

Vilobelimab is a human-mouse chimeric IgG4 kappa antibody that targets human complement component 5a, a part of the immune system that is thought to play an important role in the systemic inflammation due to SARS-CoV-2 infection that leads to COVID-19 disease progression.

Expert Opinion

A pragmatic, adaptive, randomized, multicenter phase II/III study evaluating vilobelimab for the treatment of severe COVID-19 found that patients receiving invasive mechanical ventilation and usual care who were treated with vilobelimab had a lower risk of death by day 28 and day 60 compared to those receiving placebo. This manuscript explores what is known about vilobelimab and explores how this treatment may be used in the future to treat severe COVID-19.

KEYWORDS:

• Complement
• SARS-CoV-2
• COVID-19
• vilobelimab
• complement
• C5a
• Gohibic

Article highlights

• Severe COVID-19 has been associated with both direct viral tissue damage due to SARS-CoV-2 infection as well as an exuberant host immune response.

• In response to SARS-CoV-2, activation of the host’s complement system due to viral protein toxicity and cytokine-induced systemic inflammatory response may also contribute to pathogenesis.

• Complement overactivation in the setting of SARS-CoV-2 infection may lead to hyperinflammation, coagulopathy, and pulmonary injury.

• Complement hyperactivation has been observed in patients with severe COVID-19.

• Vilobelimab (previously IFX-1) is a monoclonal antibody that specifically binds to human complement split product C5a.

• Vilobelimab has been shown to improve mortality in patients with severe COVID-19 who are receiving mechanical ventilation.

Declaration of Interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.