NEW YORK, May 4, 2020 /PRNewswire/ -- Hospital for Special Surgery (HSS) is now participating in a nationwide clinical trial investigating whether an oral drug called hydroxychloroquine can effectively prevent COVID-19 in healthy healthcare workers. Known as the Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine (HERO-HCQ) trial, the study was launched by the National Patient-Centered Clinical Research Network (PCORnet) and will track responses in an estimated 15,000 participants across the country to see if they test positive for COVID-19 and whether they develop antibodies to SARS-CoV-2, the virus that causes the disease.
"The HERO-HCQ trial is more than an important opportunity to evaluate the effectiveness of hydroxychloroquine as a preventative measure against COVID-19. We also hope to learn a lot more about the disease and how it affects healthcare workers and their families," said Andy O. Miller, MD, an infectious disease specialist at HSS who is part of the leadership team responding to the COVID-19 pandemic and spearheading the trial. "We're calling on HSS healthcare workers to share their perspectives so that we can understand and provide answers to the problems they face in real time — and over time."
Hydroxychloroquine (Plaquenil®) is an oral prescription medication approved by the US Food & Drug Administration for the treatment of malaria and autoimmune diseases such as lupus and arthritis. "There is a lot of interest in testing this drug as a preventative agent for COVID-19 because it appeared to block SARS-CoV-2 from entering cells in lab studies," explained Emily Margaret Stein, MD, MS, an internal medicine specialist and clinical researcher at HSS who is collaborating with Dr. Miller on the HERO-HCQ trial. "But like all medications, there are potential risks as well as benefits. Before we make recommendations on who should or should not be taking hydroxychloroquine, we need solid evidence."
Researchers at the Duke University Clinical Research Institute designed and are leading the nationwide HERO-HCQ trial. The Patient-Centered Outcomes Research Institute is providing up to $50 million in funding. As partners of the INSIGHT Clinical Research Network, the PCORnet affiliate organization in New York City, HSS, along with New-York Presbyterian/Weill Cornell Medical Center, Columbia University Medical Center and Mount Sinai Hospital are collaborating on the trial since they are caring for large numbers of patients with COVID-19. "HSS has long been working with PCORnet to answer big healthcare questions," said Dr. Stein. "COVID-19 is the challenge we are facing today."
All healthcare workers who provide care, supplies or services to patients at HSS —including doctors, nurses, registrars, housekeepers, food delivery staff and janitors — can register to see if they are eligible to participate in the study. People with existing conditions, such as renal disease or heart conditions that put them at risk for known adverse effects associated with the drug, will not be eligible to participate.
Dr. Miller and Dr. Stein hope to recruit at least 350 study volunteers at HSS. As a double-blind, randomized, placebo-controlled study, participants will take either hydroxychloroquine or a placebo tablet once daily for 30 days. Clinical assessments will involve nasopharyngeal swab tests for COVID-19 and blood tests to detect the presence of antibodies at the beginning of the study and after four weeks. Researchers will also collect information about participants' health and ask them to fill out quality-of-life surveys.
The target completion date for the HERO-HCQ trial is July 2020. Different from typical studies that take months to collect and analyze data, researchers will analyze data from the study every two weeks. "As soon as there is clear evidence of an effect, either way, the lead investigators will stop the trial and make a recommendation," said Dr. Stein. "If the evidence shows the drug provides no benefit in preventing COVID-19, that will still be a useful result — we will save time and resources and look for other ways to help healthcare workers. If there is clear evidence of a benefit, they will recommend using the drug as preventative therapy."
"It's difficult to think that by doing our daily jobs, we could get sick, and we could also infect our loved ones at home," said Dr. Miller. "This is the time to be proactive, to develop ways to stay safe on the front lines. I encourage all HSS healthcare workers to be a part of HERO-HCQ—and to be part of the solution."
Learn more about the HERO Registry here.
HSS is the world's leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the tenth consecutive year), No. 3 in rheumatology by U.S. News & World Report (2019-2020), and named a leader in pediatric orthopedics by U.S. News & World Report "Best Children's Hospitals" list (2019-2020). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 130 countries. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.
SOURCE Hospital for Special Surgery