Clinical trial launched to evaluate experimental COVID-19 therapies

Clinical trial launched to evaluate experimental COVID-19 therapies

Download PDF Copy Reviewed by Emily Henderson, B.Sc. May 11 2020 Clinical leaders from the University of Kentucky's Markey Cancer Center, College of Medicine and College of Pharmacy have launched a clinical trial for experimental therapies to treat patients infected with COVID-19. The trial will investigate the effectiveness of azithromycin, ivermectin and camostat mesylate--drugs that could inhibit replication of SARS-CoV-2, the virus that causes the disease. The three will be tested either as stand-alone therapies or in combination with the antimalarial drug hydroxychloroquine. The trial has a "pick-the-winner" design, which will allow UK researchers to rapidly understand what potential therapies appear to be effective, guiding patients to treatments that work and researchers to promising drugs that warrant further investigation. We are pleased to be able to offer this clinical trial to patients with COVID-19 in Kentucky. While there is no standard treatment for COVID-19, this trial gives us the ability to test multiple therapies rapidly in order to identify the most promising agents. This rapid assessment means that the trial can quickly include and test new therapies as it identifies ones that are not effective." Dr. Susanne Arnold, medical oncologist and associate director of clinical translation at the UK Markey Cancer Center who is co-leading the trial The team plans to scale up a larger, more traditional placebo-control clinical trial using the most promising therapies with the best patient outcomes. This trial is reserved for patients both at home and in the hospital who have tested positive for COVID-19, or who have COVID-19 symptoms but have not developed severe symptoms that would require progression to ICU care. Patients must also have at least one high-risk feature, including hypertension, diabetes, cancer, lung disease, have an underlying heart condition, or be over the age of 50. Outside of the hospital, clinical care and follow-up for research will arranged in coordination with the UK Healthcare's Infectious Disease (ID) division under the direction of Dr. Alice Thornton. Researchers began consenting patients the first week of May and plan to enroll 240 patients over the course of the study. "The goal is to prevent patients from getting severe cases of the disease that would require hospitalization or put them in the ICU or on a ventilator," said Dr. Zachary Porterfield, an infectious disease expert, virologist and assistant professor of medicine at UK who is co-leading the study with Arnold. "No proven therapies have been demonstrated to prevent progression of COVID-19 to severe illness. This is a critical unmet need for high-risk individuals that would also reduce the strain on our healthcare system." Patients with cases of COVID-19 who choose to enroll in the trial will be randomly assigned to one of four treatment groups: one group will receive hydroxychloroquine alone; a second group will receive hydroxychloroquine and azithromycin; a third group will receive hydroxychloroquine and ivermectin; and a fourth group will receive camostat mesylate. "The medications were selected by a multidisciplinary committee of medical experts from across the university. These were chosen as some of the most unique and promising initial trial study drugs that can be offered at the moment. Not only do they have some data to suggest they may work against COVID-19, these are all oral medications that are widely available and could have an effect worldwide," said Porterfield. Related Stories



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