Cleveland - – University Hospitals has announced it will lead a clinical trial that involves the administration of an investigational drug, ARMS-I, to it's caregivers working on the frontlines of the COVID-19 pandemic.
The trial, named the ARMS-I COVID Study, is designed to assess whether the drug helps prevent airborne transmission of coronavirus and whether it reduces the symptoms of healthcare providers who have tested positive for the virus.
“This trial is another example of our community and biomedical industry coming together to seek solutions that help mitigate the COVID-19 outbreak,” said Daniel I. Simon, MD, Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center. “Our UH research team has been working closely with the manufacturer, ARMS Pharmaceutical, as well as Case Western Reserve University, to get this trial quickly organized, funded, and ready for roll-out. We are expecting to begin the trial within two weeks.”
The study will be conducted by the UH Clinical Research Center with Robert Salata, MD, Chairman of the Department of Medicine at UH Cleveland Medical Center, Program Director of the UH Roe Green Center for Travel Medicine & Global Health and Professor of Medicine, Epidemiology and International Health at Case Western Reserve University, serving as the principal investigator.
University Hospitals will serve as the coordinating site for the trial with other Northeast Ohio health systems participating as additional sites for recruitment. UH trial participants will include clinical staff who are directly caring for patients. This trial is a randomized placebo-controlled crossover study and during the course of the trial, everyone will get the investigational drug even if they started with the placebo.
“Our health care workers risk exposure to the coronavirus every day and it’s important to find strategies that might help them, beyond providing personal protective equipment,” said Dr. Salata. “A previous study suggested this drug might be effective as a throat spray in reducing infection. The goal of this trial is to rapidly determine whether ARMS-I is effective in providing protection against COVID-19 for frontline health workers. We will be measuring whether there is a decrease in the rate of COVID-19 infection, and also whether there is a decrease in the frequency, duration, and severity of acute upper respiratory infection in caregivers who may contract the virus.”
The ARMS-I drug was previously studied at UH in a clinical trial aimed at reducing upper respiratory infections, and ARMS Pharmaceutical currently has an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) to study the drug as a potential influenza prophylaxis.
In laboratory studies, ARMS-I has been shown to kill enveloped viruses, including influenza. COVID-19 is also an enveloped virus. The preclinical data are encouraging, but studies in humans are necessary to determine whether the product is effective against specific pathogens. The UH study is intended to address that need with regard to COVID-19. Additionally, an important study recently published in the Journal of Virology indicates that one of the active ingredients in ARMS-I has potent antiviral activity against coronavirus MERS-CoV.
“We are optimistic about the potential benefits ARMS-I may provide in the fight against COVID-19 and in protecting our health care workers,” said Afif Ghannoum, Chief Executive Officer of ARMS Pharmaceutical. “The theory is that once applied to the back of the throat, ARMS-I may work to prevent new airborne viral particles from attaching to the back of the oral cavity called the oropharynx and therefore stop transmission. If the trial is successful, as we hope, we will work closely with the FDA and other relevant authorities with the goal of swiftly securing the necessary approvals to manufacture the product in quantities necessary to broadly help protect health care workers on the frontline.”
Recognizing the unprecedented challenges faced by caregivers at health systems throughout Northeast Ohio and the critical role they will continue to play in ensuring the recovery and resilience of the community, the Cleveland Foundation has authorized $1 million in emergency funding to support a significant portion of this clinical trial from previously restricted health-related research grant dollars at the foundation.
“For more than a century, our mission has centered on enhancing the health and well-being of Greater Cleveland,” said Ronn Richard, President and Chief Executive Officer of the Cleveland Foundation. “By providing critical funding to help launch this clinical trial across multiple health systems, we are reinforcing our steadfast commitment to all of the compassionate individuals who work on the frontlines every day in service of our most vulnerable residents. We must do everything we can to support our medical community as we follow their inspired lead during this public health crisis.”
“At the Case Western Reserve University School of Medicine, we have formed COVID-19 working groups supporting research activities that aim to bring solutions to this crisis,” explained Pamela Davis, MD, Dean, Case Western Reserve University. “We hope others will join us in supporting this trial led by one of our key investigators, Dr. Salata. It’s our belief that this trial will lead to rapid improvement in the health and wellbeing of frontline health care workers in our community as well as around the world.”
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