Main Line Health part of trial to rapidly develop treatments for sickest COVID-19 patients

With the Delta variant causing the number of COVID-19 cases and deaths to climb, developing new treatments quickly and safely is critical. Led by the clinical research team at the Lankenau Institute for Medical Research (LIMR), part of Main Line Health, the health system's four acute-care hospitals are part of a cutting-edge trial designed to do just that.

Main Line Health is among 20-plus health systems-and one of the few community health systems nationwide-participating in the I-SPY COVID-19 trial, giving its critically ill COVID patients access to state-of-the-art therapies. Only patients receiving a high volume of oxygen or on a ventilator are eligible. Studies estimate that patients placed on a ventilator have only about a 50% survival rate.

The trial's unique setup involves testing four drugs concurrently in addition to administering the existing backbone of approved therapies to all eligible patients. This standard-of-care regimen includes remdesivir, an antiviral drug; dexamethasone, a steroid medication; and tocilizumab or baricitinib, which are immunomodulating drugs. Study participants have an 80% probability of receiving one of the four trial drugs added to their regimen. The other 20% are part of the control group and receive no trial drugs.

Therapies found effective after a certain number of patients are enrolled will "graduate," at which point they will be part of a larger study or, if patient improvement is robust, could move into the standard of care when appropriate. Ineffective drugs are dropped. Each time testing of a drug is completed, another is rotated into the trial.

"I'm so proud that, as a community hospital, we can be part of a collaborative with larger university centers and help in the discovery of new agents that can help our sickest patients," said Eliot Friedman, MD, the lead investigator of the I-SPY trial for Main Line Health on behalf of LIMR. "It's an important endeavor, particularly in such a tragic situation where the pandemic has caused so much loss of life."

"Throughout its nearly 100-year history, LIMR has been dedicated to moving treatments from the study bench to the patient's bedside as quickly and safely as possible," said George Prendergast, LIMR's president and CEO. "I can think of no better example of serving that mission than the I-SPY trial. We're helping make a real difference against the greatest health threat of our time."

The I-SPY platform for simultaneously testing multiple agents already had a 10-year track record of safety and effectiveness in the treatment of breast cancer when the Quantum Leap Healthcare Collaborative, a nonprofit organization focused on uniting patient care and research, provided it for COVID-19 research in April 2020.

Because it is an early phase trial, I-SPY COVID-19 involves a smaller number of patients per experimental treatment arm than later-stage trials, allowing researchers to test drugs more quickly. Once 125 patients are enrolled nationally, the treatment arm is closed, and another drug tested.

"Safety is paramount in the trial," said Paul Gilman, MD, director of LIMR's clinical research center. "Unlike standard clinical trials, efficacy and safety data that are collected and analyzed during the course of it can lead to modifications of the trial while it is being conducted. Measures of safety are tracked and reported by the research team at Main Line Health and monitored by a national safety committee. Ongoing evaluation of safety is critical to the conduct of the trial and our ability to offer these state-of-the-art therapies."

Some of the drugs being evaluated have been around for many years and are approved for other uses. Others are new.

Patients and caregivers generally have one of two reactions when offered the chance to participate, said Christina Angelucci, who is senior clinical research coordinator for LIMR and oversees day-to-day operation of the trial. Some are resistant, although often they still can be convinced to participate.

"We need to remind them that we are just adding to the standard of care they are already receiving," Angelucci said. "Plus, they get another layer of oversight, because they have our team along with the physician team already treating them."

Others want to start as soon as possible. In fact, after receiving the prescribed four days of a monoclonal antibody treatment, one man was doing so well he asked if he could stay on it an extra day.

"I had to tell him, 'Sir, that's not how it works!'" she said, laughing. "But it was great. He was really seeing such a positive result from the infusion. It kind of put a smile on everyone's face who interacted with him and assisted with his care here."

Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR's mission is to improve human health and well-being. Faculty and staff are devoted to advancing innovative new approaches to formidable medical challenges, including cancer, cardiovascular disease, gastrointestinal disorders and autoimmune diseases, such as diabetes and arthritis. LIMR's principal investigators conduct basic, preclinical and translational research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health's commitment-to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers-reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health's core are four of the region's most respected acute care hospitals-Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital-as well as one of the nation's recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region's largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation's highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association's #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

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