An Athens research facility has been chosen as one of 150 sites to test a potential vaccine against COVID-19, the disease caused by the novel coronavirus.
Tonya Pryor, director of research at North Alabama Research Center in Athens, said NARC and its sister site, Medical-Affiliated Research Center in Huntsville, were each chosen to conduct trials of a new drug from Pfizer that could serve as a COVID-19 vaccine.
Pryor explained that as a Phase 3 trial, this will mean North Alabamians who are chosen for the study will basically serve as medical heroes, helping researchers as they work to find a solution to a virus that has killed more than 135,000 Americans so far. It also means they'll be looking for more patients than they were in Phases 1 and 2, and it will serve as an outpatient study that focuses on "confirming and expanding the safety and effectiveness of the results shown in Phase 1 and Phase 2," Pryor said.
In Athens and Huntsville, the goal is 300 patients per facility with 50% receiving the vaccine and 50% receiving a placebo. Enrollment could begin within the next month, Pryor said.
"We only have three to four months to get those patients," she said. "We will follow those patients who make it into the study for 26 months to make sure they're doing OK. They'll have a patient diary, and they will report any signs or symptoms that they have, how they're feeling, if they have anything going on."
Patients will also receive free medical care related to the study, including COVID-19 testing, antibody testing, EKGs, blood and lab work, physical assessments and more. To participate, patients must meet certain criteria, including: no cancer in the last five years, no previous diagnosis of COVID-19, no autoimmune disorders or unmanaged pre-existing conditions and being an adult under the age of 85. Other restrictions may apply.
Those who qualify will also be financially compensated. As an outpatient study, Pryor said patients could expect to spend two hours on their first visit, then have much shorter visits with staff as the study continues.
The facilities are hiring additional staff to ensure patients can receive support 24/7 during the trial, and they will be working with area physicians, she said.
Dr. David Pryor, soon-to-be-former Athens-Limestone Hospital president, will be overseeing the study at the Athens and Huntsville locations. Tonya Pryor said it wasn't a requirement, but "it's a huge benefit to have him on board."
Other studies by NARC and MARC include medications for irritable bowel syndrome, chronic obstructive pulmonary disease, diabetes, urinary tract infections, acid reflux and cholesterol. Pryor encouraged anyone interested in participating to contact NARC after the enrollment period begins and/or consult with their primary care physician.
Alabama, like many states across the nation, continues to see a rise in confirmed cases of the novel coronavirus. Limestone County reported its first death from the virus one week ago, with two more confirmed deaths and a probable death from the disease reported in the days after.
The Alabama Department of Public Health reports 1,096 Alabamians have died total since they first began reporting numbers in March. Since then, more than 7,100 Alabamians have been hospitalized and 54,768 cases have been confirmed.
In Limestone County, there have been at least 665 cases so far, with 25% of those cases added in the last week.
However, health experts have said it is not so much the number of cases but the rate at which tests return positive that leaves them concerned, and at the local level, 12.8% of tests have come back positive in the last two weeks. By comparison, The News Courier reported positive test rates in the county of 11.5% in the two weeks leading up to June 27 and 11.9% in the two weeks leading up to July 8, according to data from ADPH.
That data also shows an increase statewide, up from 10.6% for the two weeks prior to July 8 to 12.1% for the two weeks prior to July 13. ADPH reported a single-week high of 14.6% for the week of June 28 to July 4.
For most people, COVID-19 causes mild to moderate symptoms, such as fever and cough, though it can be passed by people with no symptoms at all and cause severe symptoms or death. To reduce the spread of the virus, individuals are encouraged to follow health guidelines, including practicing social distancing, washing their hands and wearing a face mask in public settings.