As part of its new COVID Research Program, Atlantic Health System is enrolling hospitalized patients with severe COVID-19 in the PRE-VENT phase 3 multicenter clinical trial of pacritinib, an investigational cancer drug. The study will explore pacritinib as a treatment for cytokine storm in hospitalized patients with severe COVID-19. Cytokine storm, a type of severe immune overreaction that has presented in severely ill patients with COVID-19, can cause life-threatening respiratory complications. The placebo-controlled study will look at whether this unique drug can prevent COVID progression to acute respiratory distress syndrome (ARDS) and mechanical ventilation. Atlantic Health System is the only New Jersey site enrolling patients at Morristown Medical Center, Overlook Medical Center in Summit and Chilton Medical Center in Pompton Plains.
“Patients with severe COVID-19, particularly those with cancer, are at a high risk for complications and urgently need treatment options,” said Eric Whitman, MD, medical director, Atlantic Health System Cancer Care and local principal investigator (PI) for the study. “Pacritinib is promising due to its unique mode of action and potential to prevent an inflammatory response in patients with COVID-19 infection.”
The PRE-VENT study is sponsored by CTI BioPharma, a leading biopharmaceutical company based in Seattle focused on the development and commercialization of drugs that meet unmet needs in patients suffering from blood-related cancers. Pacritinib is a new type of oral kinase inhibitor—a drug that blocks enzymes that may cause cancer cells to grow. As a multi-kinase inhibitor, pacritinib has the potential to prevent an inflammatory response that frequently leads to respiratory failure and the need for mechanical ventilation in severe COVID-19.
“The Atlantic Center for Research is proud to offer this clinical trial as one of a number of studies in our leading-edge COVID Research Program,” said John Halperin, MD, medical director, Atlantic Center for Research. “We have long been a leader in clinical research, and our research team has gone ‘above and beyond’ to add to our diverse science portfolio by getting the COVID Research Program up and running.”
PRE-VENT is a phase 3, randomized, double-blind placebo-controlled multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. Half of patients will receive pacritinib plus standard of care, while the other half will receive an inert substance (placebo) plus standard of care. Most study participants will receive the drug or placebo for two weeks. If, after day 14, the clinical care team determines that a study participant’s symptoms are improving and the potential benefit outweighs the potential risk, the participant may be given the assigned therapy for an additional week. Patients discharged from the hospital will complete their study treatment on an outpatient basis.
For more information about this study, please call the research coordinator at 201-572-9943 or email: email@example.com.
Atlantic Health System is leading 15 COVID clinical trials and continues to add studies to the COVID Research Program.
To learn more about COVID-19 clinical trials at Atlantic Health System, visit www.atlantichealth.org/research and search for “COVID.”
About Atlantic Center for Research
The Atlantic Center for Research serves as the focal point for clinical and translational research at the Atlantic Health System, a leading health system in New Jersey. Clinical and translational studies at Atlantic Health System aim to advance the care of patients with cancer, heart disease, complex neurological and neurosurgical conditions, childhood disease and, most recently, COVID-19. COVID-19 trials brought together experts in these specialties, as well as those in pulmonary-critical care, infectious diseases, oncology-hematology and rheumatology. The Atlantic Center for Research provided the critical infrastructure that made possible the rapid implementation and management of these highly varied studies, providing the means by which research could be rapidly and efficiently implemented outside of a university hospital-based system, bringing healthcare innovation and cutting-edge treatment directly to patients in their local communities.
To learn more about COVID-19 clinical trials at Atlantic Health System, visit www.atlantichealth.org/research.