Austin Regional Clinic studying Pfizer pill to lessen COVID-19 symptoms
Austin Regional Clinic's research arm is beginning to enroll people into Pfizer's "COVID pill" study.
The pill can be thought of like a Tamiflu, which is given to lessen the symptoms of flu. Recipients take the COVID treatment pill twice a day for five days. Researchers hope to prove that the pill will lessen the symptoms experienced by patients and possibly can prevent people who have been exposed to someone with COVID-19 from getting sick at all.
ARC Clinical Research has previously participated in Pfizer vaccine trials across all age groups.
ARC Clinical Research is enrolling three types of people in this study: low-risk people who have tested positive for COVID-19 in the last 72 hours; high-risk people who have tested positive for COVID-19 in the last 72 hours; and people who are in the same household as a person who has recently tested positive for COVID-19.
People are considered high risk if they are 60 years old or older, have a body mass index above 25, chronic kidney disease, diabetes, an immunosuppressive disease, cancer, heart disease or chronic lung disease.
Everyone enrolled in the study has to be unvaccinated and 18 years old or older. Half of the people enrolled will receive the study drug, the other half will receive a placebo. The participants and their physicians will not know who received which.
ARC was involved in the initial trial phase of this medication, which enrolled 60 people throughout the world. It enrolled one woman who qualified as high risk because of her BMI.
Researcher Dr. Amy Siegel, an internal medicine doctor at ARC and principal investigator for this trial locally, said while she enrolled that participant, she does not know if that patient received the COVID pill or received a placebo. She says she knows that patient did well and stayed out of the hospital, while her husband was hospitalized.
In the trial, the COVID pill is given in a 300 milligram dose, either as three 100 milligram pills, or two 150 milligram pills. The medication is given along with the well-known HIV drug ritonavir, which is a protease inhibitor.
The trial participants will attend 10 to 12 medical visits and get paid $100 a visit. They have to keep a log of their symptoms, and log their oxygen levels and temperature.
"The main hope is that it decreases the hospitalization and death so that COVID becomes more manageable like a regular cold," Siegel says. "COVID right now is nothing like a regular cold."
COVID-19 is also highly unpredictable, she says, because "everybody takes such a different course with COVID."
If this pill is successful, it will not replace a vaccine. Siegel compares it to the flu's symptom-reducing Tamiflu. "Even with Tamiflu, people still die of the flu, and (COVID-19) is much more deadly than the flu," she says. "Even though there is Tamiflu, we still have flu shots."
To enroll in a study at ARC Clinical Research, go to austinregionalclinic.com/services/clinical-research.