Atlanta (May 15, 2020) – Piedmont Healthcare announced Friday it is participating in the U.S. Food and Drug Administration’s (FDA) expanded access program for the antiviral drug remdesivir, which was granted emergency use authorization on May 1. The investigational drug was shown in a clinical trial to shorten the recovery time in some COVID-19 patients.
“Piedmont’s providers have been on the front lines of the COVID-19 pandemic and remdesivir gives them another tool to help care for our patients,” Charles L. Brown, III, M.D., CEO of Piedmont Healthcare’s Physician Enterprise said in a press release.
The program is available for patients at Piedmont Atlanta Hospital, Piedmont Fayette Hospital and Piedmont Columbus Regional-Midtown Campus and may be expanded to other Piedmont hospitals, Piedmont officials announced. Previously, Piedmont participated in the FDA’s compassionate use program for remdesivir.
This is not the first instance of Piedmont’s participation in efforts to combat COVID-19. It recently announced that it would participate in two new clinical trials that will investigate therapies for patients who are positive for COVID-19: one that will evaluate the efficacy of the anti-inflammatory drug Gimsilumab and another that will investigate proning or repositioning patients to improve their oxygen levels. These studies began enrolling patients in early May.
“Piedmont’s mission is to serve its patients and by offering clinical trials designed to fight COVID-19 during this pandemic, we are delivering on our promise,” Brown said on making that announcement.
The studies are officially named “A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19,” or BREATHE, and “Awake Prone Positioning for Early hypoxemia in COVID-19” or APPEX-19.
John Manasso, the spokesman for Piedmont Healthcare, said it is possible that patients from the local area could end up being enrolled in these trials.
“If Walton patients are transferred to Atlanta, they could be enrolled in these trials. In addition, the BREATHE trial will open at Piedmont Athens in a few weeks and Piedmont Walton is part of our east hub (Piedmont Athens) so they also most might be able to enroll in that trial if they are hospitalized at Piedmont Athens,” Manasso said.
Amy Hajari Case, M.D., is Piedmont’s Medical Director of Pulmonary and Critical Care Research and principal site investigator for this program at Piedmont Atlanta.
“Piedmont’s purpose is to make a positive difference in every life we touch and by offering novel treatments to care for our COVID-19 patients, we are delivering on our promise,” Case said. “We had a positive experience with remdesivir early in the pandemic and are excited to be able to provide to our patients again.”
FDA expanded access programs, sometimes called “compassionate use,” represent a process by which patients with immediately life-threatening conditions or a serious disease can gain access to an investigational medical product for treatment outside of clinical trials when no comparable or alternative therapy options are available.
To learn more about these trials, visit https://www.piedmont.org/research/research-home.
About Piedmont Healthcare
Piedmont Healthcare empowers communities to connect with safe and high-quality care, conveniently, every step of the way. Our promise is to make a positive difference in every life we touch and today we are creating a destination known for the best clinicians and a safe one-of-a-kind experience that always puts patients first. Founded in 1905, we are a private, not-for-profit organization with over 23,000 employees serving 2.7 million patients across 800 locations and serving communities that comprise 70 percent of Georgia’s population. Piedmont provides safe, convenient and high-quality care across 11 hospitals, 34 Piedmont Urgent Care centers, 28 QuickCare locations, 555 Piedmont Clinic physician practice locations and more than 2,500 Piedmont Clinic members. In 2019, Forbes listed us as one of the Top10 Employers in Georgia, Piedmont became Great Place to Work-Certified™, which was repeated in 2020, and is the safest health care system in Georgia. In FY 2019, Piedmont provided $340 million in uncompensated care and community benefit programming to the communities we serve. For more information, visit piedmont.org.