The Tidewater Physicians Multispeciality Group is studying people who tested positive for the coronavirus.
The trial is open to people with COVID-19 symptoms and those 12 years and older.
Volunteers get up to $400 for participating in the study.
Dr. Vijay Subramaniam, a pulmonologist at TPMG, is the medical director for the trial and principal investigator for the study.
He said TPMG is one of five sites in the country doing the “double blinded” Phase 3 study sponsored by by COVIS Pharma. Half of the volunteers participating will be on the medicine, while the other half are on the placebo.
Subramaniam said they won’t know who is on either the medicine or the placebo.
The medicine, Alvesco (Ciclesonide) has already been approved to treat asthma, and this study would get approval for COVID-19 treatments, he added. While there is a side effect associated with the inhaler, like throat irritation, Subramaniam said if the person rinses their mouth, they should be fine.
As of Tuesday, 20 people are participating in the study and TPMG plans to accept new volunteers until they get 100 people. The study runs for approximately 60 to 90 days with results expected in late August to early September.
Once the trial is complete the drug can go to FDA for approval.
“The big thing is it’s already an FDA-approved medicine,”Subramaniam said. “It’s been well studied and proven to be safe for the treatment of asthma so there’s not a lot of risks with this study. And it could be beneficial for the patient and absolutely beneficial for science and pretty much everyone else out there.”
In order to participate in the study, volunteers must be have been diagnosed as positive within 72 hours, experience COVID-19 symptoms such as fever, cough, shortness of breath or loss of taste or smell and be willing to document their experience in a “digital diary.”
While most of the study is done virtually, the patient will have to come in for a nasal swab and be shown how to use the inhaler. Each person will get an electronic diary to complete using the person’s cellphone or given an electronic device.
For more information or to volunteer for this study, call 757-741-0981 or email clinicaltrials@tpmgpc.com.
EDITOR’S NOTE: A WYDaily reporter who initially interviewed the doctor for this story has decided to participate in the study. Writing the story was assigned to another reporter to avoid a conflict of interest.
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