Buffalo News: UB researchers launch study to learn if an asthma treatment can ease Covid-19

Released: 6/19/2020 3:46:09 PM

By Scott Scanlon
Published Thu, Jun 18, 2020
 
Emergency medicine researchers in Buffalo have launched a study to see if a steroid medication typically used to treat asthma can help patients sick at home with Covid-19.

“Some people with viruses or other illnesses feel better sooner, faster with these kinds of medicines, so our hope in this case is that it will be helpful too,” said Dr. Brian Clemency, associate professor in the Department of Emergency Medicine in the University at Buffalo Jacobs School of Medicine and Biomedical Sciences.

Doctors and EMTs will use telehealth and home visits to monitor patients who volunteer to take ciclesonide by inhaler twice daily for a month to see if it eases the course of the disease caused by the novel coronavirus.

Clemency, who has worked for more than a decade in the Emergency Department at Erie County Medical Center, said Wednesday that the study will involve up to 400 patients from four metro areas across the United States, with results expected by late summer.

Drug-maker Covis Pharma, based in Luxembourg, also announced similar clinical trials in Australia, Japan, South Korea, Sweden and the United Kingdom.

Most Covid-19 studies so far have targeted the sickest of hospitalized patients but that can change now that testing for presence of the disease has become more available. This means studies such as this one should help doctors better treat all patients with symptoms, Clemency said.

“Most patients who are going to be discharged from an emergency room are given Tylenol and other over-the-counter supportive medicines,” he said. “Our hope is that this study will show that there is a prescription medicine that can help them feel better sooner.”

Health care providers give most other experimental Covid-19 treatments intravenously. Those therapies circulate throughout the body, while ciclesonide is directed into the lungs, “where people who have severe illness often have most of their complaints,” said Clemency, who last month published a study that suggested the loss of taste and smell are the most likely symptoms to predict a positive Covid-19 test result.

Half of patients in the new clinical trial will receive the corticosteroid and half will get a placebo. The goal is to find out whether ciclesonide (brand name Alvesco) reduces symptoms, as well as  hospitalization and death rates of those enrolled.

Ciclesonide is normally used as a long-term maintenance therapy to prevent and ease asthma symptoms. It was launched in 2006 and costs about $300 for a 20-day supply at the dosage used in the study. Those who enroll will receive the medication free and be paid to participate.

“We use a lot of inhaled steroids in gum disease, asthma and COPD," said Dr. Sanjay Sethi, director of the UB Clinical Research Office, who helped Clemency set up the study in the region. "These are some of our major anti-inflammatory drugs, but interestingly, what we’ve also found is this drug has some antiviral activity.”

Those who believe they might be eligible for the study must reach out to researchers within 72 hours after taking a Covid-19 swab test. They need to test positive, be at least 12 years old and have symptoms that include a cough or shortness of breath. Researchers are available seven days a week at 716-427-6643 .

EMTs from American Medical Response will visit study participants at the start and end of the process. They will collect samples, show them how to complete twice-daily online journals and help connect them by computer or smartphone to members of the study team, who will touch base every other day.

UBMD Emergency Medicine has used telehealth to treat state prison inmates for more than a decade, Clemency said, and set up a similar system when the pandemic started in March for people who preferred remote treatment instead of a visit to ECMC or Kaleida Health hospital emergency rooms.

News of the study comes as medical researchers at Oxford University reported this week that dexamethasone, an inexpensive steroid developed six decades ago to treat arthritis, has proven effective in some of the sickest Covid-19 patients in England.

Both medications reduce inflammation, which in proper amounts promotes healing but in excess worsens chronic and emergent disease. In the most serious Covid-19 cases, an overactive immune response spawns a cytokine storm, or burst of inflammation that endangers breathing and other bodily functions.

Sethi called the dexamethasone study heartening in both scope and findings, but said more evaluation is needed.

UB researchers continue to conduct several Covid-19-related clincal studies, including another about to start with some of the sickest patients in the region. Researchers want to know if APL-9, an intravenous anti-inflammatory treatment, can limit respiratory failure and blood clots, two leading causes of novel coronavirus death.

Meanwhile, Sethi recommended the common sense advice given by infectious disease control experts since the pandemic began in March.

"Social distancing, and masking, especially when you can't social distance, are important," he said. "And avoid big gatherings. Those three major things are the reason why our Covid-19 case numbers are declining."