By Christine Davis
Patients admitted with COVID-19 at Boca Raton Regional Hospital may enroll in a clinical trial to test a new treatment for the disease. The trial is named Prevent, reflecting the hope that it will rapidly reverse the damages of pneumonia associated with COVID-19.
Researchers at Eugene M. & Christine E. Lynn Cancer Institute are enrolling patients for the trial, which uses a single, low dose of thoracic radiation to reduce the inflammatory process in the lungs. Very low doses have been effective in treating benign inflammatory diseases.
Experts say the treatment may prevent deaths and avoid the need for intubation.
Patients diagnosed within nine days of hospital admission with pulmonary pneumonia symptoms and 50 years of age or older are eligible for the trial. The Prevent multicenter clinical trial is jointly led by principal investigators from Lynn Cancer Institute and the Ohio State University. The trial is one of several investigational treatments for COVID-19 being researched at Boca Raton Regional Hospital.
Certified clinical research coordinator David Scott, president and CEO of Palm Beach Research in West Palm Beach, announced that Palm Beach Research is enrolling people for two phase 3 trials regarding COVID-19.
The Janssen’s study, of an adenovirus type 26 vector vaccine, is a two-year project for which Palm Beach Research will provide access to COVID-19 testing and related medical care. Participants will be compensated for every visit, up to a total of $775. Half of the patients will get the vaccine and the other half a placebo.
“Janssen’s vaccine is constructed to encode the COVID-19 spike protein. It is like a genetically engineered cold virus meant to look like the COVID-19 virus outer shell. So, your body will produce antibodies to remove that protein shell whenever it sees it. Thus, it trains your body’s immune system,” Scott explained.
To take part, visit https://palmbeachresearch.com/2020/03/02/covid-19-vaccine-study/
AstraZeneca’s convalescent study is of a prophylaxis, an infusion of antibodies intended to provide immediate protection from COVID-19. It is a one-year study, and during that time Palm Beach Research will provide access to COVID-19 testing and related medical care to participants. Patients will be compensated for every visit, up to a total of $850.
About one-third of the patients will get the placebo and the remaining two-thirds the convalescent plasma.
“AstraZeneca’s convalescent plasma study is providing patients with an infusion of antibodies that should provide protection against COVID-19, as the antibody (formula) came from hospitalized patients who recovered from a bad COVID-19 infection. This is not training your body’s immune system: It is providing immediate immunity,” Scott explained.
To take part, visit https://palmbeachresearch.com/2019/12/09/convalescentplasma/
Asked when patients receiving placebos would get an actual vaccine or plasma, Scott said: “Patients receiving placebo are enrolled in the clinical trial and the sponsors have been providing active product or vaccine after reaching important study milestones. The short answer is the protocol does not need a patient on placebo after a certain point, and the sponsors grant access to active product to those patients, at that point. Every sponsor is different.”
An optimistic time line for public access to vaccines may be the summer or fall of 2021, he thinks, adding: “If the FDA rescinds emergency use authorization, then the general public will have to wait until the clinical trials are concluded. The earliest would be October 2022.
“Vaccination through a clinical trial is the fastest path for most. Additionally, medical care is provided and ongoing in a clinical trial setting. Also patients are compensated for their time. And anyone receiving a placebo can expect to receive the actual product in due course.
“As an example, the Moderna vaccine trial will be distributing active vaccine to the 15,000 that received placebo in their clinical trial, and that is expected to occur possibly January 2021. Every sponsor is expected to follow a similar path.”
A related note: To see the current COVID hospital capacities, check out https://data.tallahassee.com/covid-19-hospital-capacity/.
Hilary Shapiro-Wright, D.O., has joined Christine E. Lynn Women’s Health & Wellness Institute and Eugene M. & Christine E. Lynn Cancer Institute at Boca Regional. She specializes in breast cancer surgery, high-risk breast pathology, benign breast disease, oncoplastic surgery and hidden scar surgery.
Previously, Shapiro-Wright was with the Kettering Health Network and Kettering Cancer Care. She was named the Cincinnati Top Doctor in Breast Surgery/Breast Cancer in Cincinnati magazine from 2013 to 2020.
She earned her medical degree from the Lake Erie College of Osteopathic Medicine and completed her general surgery residency at Botsford Hospital at Michigan State University and her surgical breast oncology and diseases of the breast fellowship at Allegheny General Hospital.
She sees patients at Lynn Women’s Health & Wellness Institute, 690 Meadows Road, Boca Raton.
In December, palliative care physician Patricia Jacobs, M.D., joined the Eugene M. & Christine E. Lynn Cancer Institute. Jacobs provides care that addresses a cancer patient’s physical symptoms as well as the emotional, psychological and social stress of undergoing cancer treatment.
Previously, Jacobs was at UCLA Medical Center, where she completed a hospice and palliative medicine fellowship. She is board-certified in internal medicine and worked in internal medicine before pursuing a subspecialty in palliative care.
Jacobs serves as an affiliate faculty member at the Charles E. Schmidt College of Medicine at Florida Atlantic University. She earned her medical degree from the David Geffen School of Medicine at UCLA. She completed an internal medicine residency and a hospice and palliative care fellowship at UCLA Medical Center.
She sees patients at the Lynn Cancer Institute, Harvey & Phyllis Sandler Pavilion, 701 NW 13th St., Boca Raton.
Joseph J. Ricotta MD, MS, DFSVS, FACS, was recognized as a 2020 TCAR clinical operator of experience for improving carotid artery disease treatment using the transcarotid artery revascularization procedure.
Ricotta is the national medical director of vascular surgery and endovascular therapy for Tenet Healthcare, chairman of the vascular surgery department at Delray Medical Center, and professor of surgery and program director of the vascular surgery fellowship at the Charles E. Schmidt College of Medicine at FAU.
TCAR is a proven, minimally invasive approach to reduce incidence of stroke in patients who face high risk in surgery. For more information, visit www.delraymedicalctr.com.
Dr. Eric Rudnick, MD FAAD, recently received his board certification in dermatopathology. As both a board-certified dermatologist and dermatopathologist, he has the training to analyze skin samples both clinically as well as under a microscope. Rudnick’s Dazzling Dermatology office is at 22029 State Road 7, Boca Raton, Florida. He is offering at-home general dermatology and cosmetic services. For information or to book a house call, visit https://dazzlingderm.com or call 561-923-0905.
Delray Medical Center’s trauma research department earned awards at the 2020 Florida Atlantic University College of Medicine Research Day event. Sarah Rabinowitz was awarded both first and second places in the Research Poster competition for her work related to the transfer of patients with abdominal injuries.
With the goal of promoting lifelong learning opportunities for its registered nurses, the Health Care District of Palm Beach County signed a memorandum of understanding with Palm Beach State College to support Health Care District RNs in obtaining Palm Beach State’s bachelor of science in nursing degrees.
This “RN to BSN” bridge program, sanctioned by the Accreditation Commission for Education in Nursing, is offered online and open exclusively to licensed registered nurses who have earned an associate’s degree or diploma. The Health Care District nurses will add to the more than 400 RNs from the state who have earned the college’s BSN degree to date.