HERSHEY, Pa. — Penn State Health Milton S. Hershey Medical Center has begun enrolling participants in an international clinical trial evaluating an investigational antiviral drug, remdesivir, for treatment of coronavirus disease 2019 (COVID-19). Remdesivir has been previously tested in humans with Ebola virus disease and has shown some therapeutic benefit against SARS and MERS coronaviruses in animal models.
There are no specific therapeutics approved by the U.S. Food and Drug Administration to treat people with COVID-19, which has sickened almost 2 million people and caused more than 124,000 deaths worldwide as of April 14. The trial will assess the safety and efficacy of remdesivir in hospitalized patients with moderate-to-severe COVID-19.
“Health care providers around the world are looking for effective therapies to treat COVID-19,” said Dr. Catharine Paules, an infectious disease physician with Penn State Health. “This clinical trial provides us with an opportunity to begin investigating whether this experimental therapy may be safe and helpful to patients in our community and beyond.”
Remdesivir was developed by Gilead Sciences Inc., and is not approved anywhere globally for use outside of clinical trials. Preclinical data on remdesivir in MERS and SARS coronaviruses — which are similar to SARS-CoV-2, the virus that causes COVID-19 — indicate that remdesivir may have potential activity against COVID-19.
“We urgently need treatment options for COVID-19 as we continue to battle this virus,” Paules said. “We thank the trial participants who are helping contribute to the discovery of new therapies, which is a core part of why Penn State Health and Penn State College of Medicine exist.”
The Milton S. Hershey Medical Center is one of 75 sites worldwide to participate in the trial, which is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. They are the only site to offer the trial in central Pennsylvania.
Enrollment at the Hershey Medical Center site is open only to patients hospitalized with COVID-19. The clinical trial is randomized, controlled and double blind, meaning medical professionals and patients won’t know whether patients receive remdesivir or placebo — a solution that contains inactive ingredients.The research team will reach out to eligible hospitalized patients directly.
Dr. Neal Thomas, associate dean for clinical research at Penn State College of Medicine, said the strong efforts of staff and faculty at the Clinical Trials Office and the Office of Research Affairs have allowed Penn State to join this effort to investigate new treatments for patients diagnosed with COVID-19.
“I’m proud of how hard our clinical research staff have worked to make this trial happen,” Thomas said. “Their efforts have increased the access patients in central Pennsylvania have to leading-edge treatments for many human illnesses, now including this novel coronavirus.”
For more information, visit ClinicalTrials.gov and search identifier NCT04280705
This research is supported by the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
About the National Institutes of Health remdesivir clinical trial offered at Penn State College of Medicine
Remdesivir is an investigational intravenous drug with broad antiviral activity. It is an experimental treatment and patient participation in this clinical investigation is optional. As with any medication, side effects are possible. Participants undergo baseline physical exams before receiving treatment and are monitored throughout the trial. Participants must have laboratory-confirmed SARS-CoV-2 infection with certain respiratory symptoms. Individuals with confirmed, mild infections with cold-like symptoms or no apparent symptoms will not be included in the study. In accordance with standard clinical research protocol, eligible patients will provide informed consent to participate in this trial.