Brian Clemency, DO, is leading a clinical trial to test the effectiveness of an inhaled steroid on non-critical COVID-19 patients.

Study Looks at Inhaled Steroid Effect on COVID-19 Patients

Published July 28, 2020

Researchers in the Department of Emergency Medicine are conducting a new clinical trial to test the effectiveness of an inhaler-based medication on non-critical COVID-19 patients.

“While much of the current research focuses on critically ill patients, I am most interested in studying patients who have COVID-19 but are not sick enough to need hospitalization. ”
Associate professor of emergency medicine
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They are using in-home visits, telemedicine and emergency medical technicians (EMTs) to evaluate subjects and collect data.

“While much of the current research focuses on critically ill patients, I am most interested in studying patients who have COVID-19 but are not sick enough to need hospitalization,” says Brian Clemency, DO, associate professor of emergency medicine and director of the emergency medical services fellowship program.

“These patients make up the majority of COVID-19 cases and potentially the highest risk for the spread of the disease in our community,” he says.

Subjects Randomly Selected to Receive Steroid or Placebo

In May, Clemency published a study titled “Symptom Criteria for COVID‐19 Testing of Heath Care Workers” in the journal Academic Emergency Medicine on which symptoms are most likely to predict a positive COVID-19 diagnosis.

There are currently no approved medications to treat COVID-19 patients. This double-blinded, randomized control trial of a steroid-based medication will evaluate the drug’s efficacy in helping patients who test positive for COVID-19 feel better more quickly.

Clemency, a physician with UBMD Emergency Medicine, expects to enroll 100 subjects from Western New York over the next two months.

To be eligible to participate, subjects must have tested positive for COVID-19, be at least 12 years old, and have fever, cough and/or shortness of breath. The subjects must enroll within 72 hours of their original COVID-19 swab being taken.

Subjects will be randomly selected to receive either the steroid or a placebo for one month.

Home Visits and Online Journals to Be Utilized

In order to comply with social distancing/isolation requirements, patients will not need to travel for the study.

Instead, subjects will participate in two home visits from EMTs from American Medical Response (AMR), who will collect samples, instruct subjects how to complete twice-daily online journals and help connect the subjects with a physician or advanced practice provider via an online link.

In addition, members of the study team will speak to the study participants by phone every other day, and study subjects will be paid for their participation. EMTs from AMR have completed specialized training in order to join the study team.

EMTs and paramedics from AMR have provided support to COVID-19 testing sites, provided special interfacility transport services and sent units to assist in New York City. Now they are participating in clinical research during the COVID-19 pandemic.

Study’s Design Leverages Several Resources

David G. Ellis, MD, associate clinical professor of emergency medicine; and Renoj P. Varughese, MD, a recent graduate of the emergency medical services fellowship program, will oversee the telemedicine program.

The program will enroll new patients seven days a week using UBMD Emergency Medicine providers.

“Because patients with COVID-19 need to be on home isolation/quarantine, it would not be safe to have them travel for study evaluation,” Varughese says.

“For that reason, this study is designed in such a way that patients can participate without ever leaving their homes,” he adds. “In addition to the safety factor, it also makes the study very convenient for the patients.”

Clemency notes that the study’s design leverages several strengths of the Department of Emergency Medicine, including its ongoing COVID-19 research, its robust telemedicine program — which serves the community through both Erie County Medical Center, the Kaleida Health System and the New York State prison system — and the medical direction it provides to EMS agencies throughout Western New York.