Williamsburg doctor seeks COVID-19 patients
Researcher wants to evaluate effectiveness of new treatment
WILLIAMSBURG — A Williamsburg doctor wants to recruit local people recently diagnosed with mild to moderate cases of the coronavirus to try an experimental treatment.
In one of the few studies across the country involving COVID-19 patients who are not sick enough to be in a hospital, researchers are testing the effectiveness of ciclesonide, a drug commonly used in the long-term treatment of asthma.
Dr. Vijay Subramaniam, the principal investigator for the research at Tidewater Physicians Multispecialty Group, thinks the medication could be helpful in battling the infectious disease.
“When we heard about this, we were extremely interested in it,” Subramaniam said. “If we could do something to help our community and our patients in any way, we would.”
So far the respiratory illness has no approved vaccines or treatments. Its swift spread and voluminous death toll have spurred a gold rush in the pharmaceutical industry, with drug developers and academic research institutions racing to discover potential therapies.
Subramaniam said the medical group was first approached to participate in the clinical trial because of its location. Early in the outbreak, the Hampton Roads peninsula was considered a hot spot for the virus, with a cluster of deaths and hospitalizations.
Across Virginia, more than 6,300 people have been admitted to a hospital for the illness and over 1,800 have died.
While many clinical studies are funded by universities and federal agencies, others are sponsored by drug makers. Covis Pharma, the manufacturer of the asthma maintenance drug, is paying the medical group and three other U.S. sites — in Winston-Salem, North Carolina, Buffalo and Atlanta — to run the trial.
The idea is that the corticosteroid inhaler, which the drug company markets as Alvesco, could decrease a coronavirus patient’s inflammation and prevent the virus’ growth. Researchers will look at whether the inhaler improves symptoms and reduces hospitalizations and deaths.
As with any drug, patients could experience side effects. Some of the most common, according to Covis Pharma, are headache, the common cold, sinusitis, larynx pain, upper respiratory infection, nasal congestion and back pain.
The study, which is in phase 3, will be open to about 100 people in the area who are 12 and older. To qualify as a participant, the patient needs to contact the research team within about three days of receiving a positive nasal swab test. Eligible candidates are those who have the symptoms — fever, cough and shortness of breath — but are not hospitalized and aren’t taking other steroids.
Half of the patients who sign up will receive the medicine, and the others will get a placebo. Neither the patients nor the local investigators will know who got ciclesonide doses until the study closes later this year.
The participants will get an inhaler to use twice a day, a meter to record their oxygen levels — and about $400 for their time. The pay comes out of the budget the medical group receives from the manufacturer, Subramaniam said.
Earlier this week, only seven patients had enrolled.
“It’s really just trying to get the word out,” he said.
Subramaniam, who is a pulmonologist, said volunteers will have two face-to-face appointments, but the majority of visits will be performed over the phone or with a video chat. Participants are asked to use an app on their phones to record their symptoms.
In the beginning, patients will be given an in-person exam to check their oxygen levels and discuss the study. After 30 days, they will come back to take a nasal swab test that measures their viral load.
Though it’s not known whether volunteers will get a better health outcome from their participation, Subramaniam said people may appreciate knowing they have a team devoted to monitoring their illness.
Many people who test positive for COVID-19 are simply told to isolate and are given little other direction. Even while study participants are home, a medical team is overseeing their electronic diaries and looking out for problems, Subramaniam said.
“They’re not being left out kind of alone. That’s a big important part of this,” he said. “It’s more the, ‘Hey, you guys are giving us someone to talk to.’ ”
For information on the clinical trial, call 757-741-0981 or email clinicaltrials@tpmgpc.com.