Researchers from the Department of Emergency Medicine at the University of Buffalo Jacobs School of Medicine and Biomedical Sciences initiated a clinical trial evaluating whether a steroid medication typically used to treat asthma can help ill patients at home. A telehealth-enabled decentralized study enables doctors and EMTs to monitor patient participants who take ciclesonide by inhaler twice daily for 30 days in an effort to investigate if the treatment eases the course of COVID-19.
Until recently, COVID-19 clinical trials only focused on the sickest, most at risk and hospitalized patients. However, with the advent of more pervasive testing research teams, whether part of academic medical centers, hospitals, and community clinics can now support studies, such as this present virtual, decentralized study.
Involving up to 400 patients, the Phase III study involves the Erie County Medical Center. Half of the patients in this study will receive the corticosteroid while the other will receive a placebo. The study hypothesis: does ciclesonide (trade name Alvesco) reduce symptoms, as well as hospitalization and death rates of study participants? Participant subjects will not only receive free medication but also be paid.
Ciclesonide (Alvesco) is normally used as a long-term maintenance therapy to prevent and ease asthma symptoms. Launched back in 2006, the therapy has a cost of about $300 for a 20-day supply at the study dosage. The product is made by Covis Pharma.
Brian Clemency, DO, MBA, FACEP FAEMS, associate professor in the Department of Emergency Medicine in the University at Buffalo Jacobs School of Medicine and Biomedical Sciences
Sanjay Sethi, MD, director of the University of Buffalo Clinical Research Office
Call to Action: If you are based in the Buffalo, New York region and have a loved on that could benefit from this study connect with the researchers within 72 hours after the person had a COVID-19 swab test. They must be positive, 12 years or higher in age, and report symptoms that include a cough or shortness of breath. Researchers are available seven days a week via a call center at 716-427-6643