Newswise — 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 Penn State Health Milton S. Hershey Medical Center
Founded in 1963 through a gift from The Milton S. Hershey Foundation, Penn State Health Milton S. Hershey Medical Center is a leading academic medical center located in Hershey, Pa. The 548-bed Milton S. Hershey Medical Center is a provider of high-level, patient-focused medical care. Annually the Medical Center admits 29,000 patients, accepts over 1 million outpatient visits, receives 73,000 emergency room patients and performs 33,000 surgical procedures. As a Magnet-designated hospital since 2007, Hershey Medical Center employs caregivers who are dedicated to excellence and achieving superior patient and community outcomes. The Hershey Medical Center campus includes Penn State College of Medicine (Penn State’s medical school), Penn State Cancer Institute and Penn State Children’s Hospital—the region’s only children’s hospital.
About Penn State College of Medicine
Located on the campus of Penn State Health Milton S. Hershey Medical Center in Hershey, Pa., Penn State College of Medicine boasts a portfolio of nearly $100 million in funded research. Projects range from development of artificial organs and advanced diagnostics to groundbreaking cancer treatments and understanding the fundamental causes of disease. Enrolling its first students in 1967, the College of Medicine has more than 1,700 students and trainees in medicine, nursing, other health professions and biomedical research in both Hershey and State College, Pa.
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.