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 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
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 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
Both experimental drugs in the study will be paired with
remdesivir, which has shown benefit to patients with severe
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
Up to 40 U.S. sites will be involved in the study. Currently,
UTMC is one of nine facilities recruiting participants.