Seattle-area residents Ferguson Neale and Pam Pruitt are just two of more than 40 million Americans who came down with COVID-19 since the start of the pandemic. But they are hoping to make a difference.
This summer, shortly after receiving word they had tested positive, they each agreed to join a clinical trial at Fred Hutchinson Cancer Research Center for an experimental drug to knock down the virus that causes COVID-19. Each of them recovered after a mild illness.
Their willingness to be poked and prodded might help lead to a treatment that could keep COVID-19 patients out of the hospital with a simple injection — instead of an intravenous drip — of laboratory-manufactured immune proteins called monoclonal antibodies.
“It was the easiest experience,” said Neale, a 59-year-old computer systems consultant who lives with his family on Mercer Island. “They are whompin’ shots, but the only pain I felt was exposing my backside to three or four people.”
You read it right: He received an injection in each cheek of the gluteus maximus, that thick muscle better known as your butt.
It is the whole point of the trial — to see if injections of antibodies, already okayed by emergency use authorization to treat early COVID-19 cases via IV drip, can be just as effective if delivered by syringe into the fleshiest part of the shoulder or the larger muscles of the buttocks.
As a practical matter for treatment of COVID-19, this could be very important.
While IV drips of the antibody drug known as sotrovimab are now used to treat mild-to-moderate COVID-19 in high-risk patients, the number of medical facilities set up to deliver infusions of any kind is limited in a health care system already under enormous strain because of the pandemic.
“Typically, the places set up to deliver intravenous drugs are chemotherapy centers, where people are being treated for cancer and are immune-compromised. The last thing you want to do is bring in people with active COVID,” said Fred Hutch physician-scientist Dr. Adrienne Shapiro.
She is a principal investigator in the trial at the COVID-19 Clinical Research Center, or CCRC, which was set up to test treatments safely at a specialized facility, isolated from other areas of the Hutch’s South Lake Union campus.
“The real impetus is to give people treatments that can keep them out of the hospital, and to give them in less-restrictive settings,” Shapiro said. “It’s a major access issue, and an injectable treatment would be a huge convenience.”
Neale said that his bout with COVID-19 reminded him of how it feels flying a red-eye across the country.
“For the first week, it was as if every morning started like I’d just gotten off the plane,” he said. It took a full month for him to feel fully recovered, back to his routines of swimming and bicycling.
Coincidentally, both Neale and Pruitt, 69, of Mill Creek, were early breakthrough cases. These are people who contracted symptomatic COVID-19 despite being fully vaccinated against it. The two are among 17 CCRC participants in the study, known as COMET-TAIL, which is sponsored by sotrovimab developer Vir Biotechnology, in collaboration with pharmaceuticals maker GlaxoSmithKline.
The injectable antibody trial began shortly after another Vir study that used IV infusion, COMET-ICE, was stopped early because sotrovimab was quickly found to be very effective. It had shown a 79% reduction in hospitalizations or death for those who received the IV drug compared to those receiving a placebo. The CCRC was a participating site in that study as well, enrolling 13 participants.
Unlike COMET-ICE, the newer COMET-TAIL study has no placebo arm. Every participant received a shot in the buttocks or shoulder or was randomly assigned to receive the active drug in an IV infusion.
