The University of Toledo Medical Center is one of the first sites in the country to enroll patients in a National Institutes of Health study aimed at identifying promising COVID-19 treatments worthy of larger, more in-depth clinical trials.
The proof-of-concept study is intended to quickly screen out ineffective experimental treatments while rapidly advancing deployment of therapeutics that show significant benefit to hospitalized COVID-19 patients.
“This is a very important project,” said Dr. Michael Ellis, an infectious disease specialist and chief medical officer at UTMC. “Right now, we have two primary treatments for COVID-19, the antiviral drug remdesivir and the steroid dexamethasone, but we critically need additional therapeutics. The purpose of this study is to quickly identify agents that could have a big impact in keeping patients off a ventilator, getting them out of the hospital sooner and reducing fatal infections.”
The trial will enroll patients hospitalized with COVID-19 who require oxygen or mechanical ventilation who consent to participate. In the initial portion of the trial, UTMC will be treating patients selected for the clinical trial with either risankizumab or lenzilumab, which are monoclonal antibodies directed at different parts of the inflammatory response that are being investigated as potential treatments for COVID-19.
Both experimental drugs in the study will be paired with remdesivir, which has shown benefit to patients with severe COVID-19 infections.
Monoclonal antibodies are lab-made proteins based on the natural antibodies our immune system produces to fight off disease. Risankizumab was approved in 2019 for the treatment of severe plaque psoriasis. Lenzilumab is in late-stage development as a treatment for leukemia.
“As we treat COVID, our objectives are to stay safe, provide state-of-the-art care and participate in the public health response,” Ellis said. “In this study, we’re participating in a way beyond just Toledo.”
The Phase 2, adaptive, randomized, double-blind placebo-controlled trial will examine both the safety and efficacy of the monoclonal antibodies compared to remdisivir alone.
Up to 40 U.S. sites will be involved in the study. Currently, UTMC is one of nine facilities recruiting participants.