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University of Wisconsin Testing Antibody Drug on Patients

The drug, an “antibody cocktail” developed by New York-based Regeneron Pharmaceuticals, contains an antibody made by the company and another isolated from recovered COVID-19 patients.

by David Wahlberg, The Wisconsin State Journal / July 14, 2020
(TNS) - University of Wisconsin Health patients will be among those testing an experimental antibody treatment heavily backed by the federal government to see if it can treat and prevent COVID-19.
The drug, an “antibody cocktail” developed by New York-based Regeneron Pharmaceuticals, contains an antibody made by the company and another isolated from recovered COVID-19 patients. About 90 to 150 UW Health patients are expected to join clinical trials of the drug, including patients with the infection and people who don’t have it but live with someone who recently got it.
The Trump administration last week awarded Regeneron $450 million to manufacture the drug, on top of $160 million already given to develop the clinical trials. Dr. Francis Collins, director of the National Institutes of Health, said the treatment could be the most promising approach for therapeutics against the coronavirus.
“If I had to pick one, I think the monoclonal antibody cocktails have a lot going for them,” Collins said at a Senate hearing this month. “There’s all kinds of reasons to think this is the kind of virus it should work for.”
UW is one of about 100 sites participating in three studies of the drug, called REGN-COV2. One study involves hospitalized patients with COVID-19 and another includes infected patients not in the hospital. The third looks at whether the drug can stave off infection in people who live with someone who recently got the disease.
“The goal (of the third study) is to give them the antibody so that hopefully they don’t develop COVID,” said Dr. William Hartman, a UW Health anesthesiologist heading up the effort in Madison.
In each study, some patients will get relatively high levels of the infused drug, some will get low levels and some will get a placebo. Patients and doctors won’t know which group patients are in, Hartman said.
Few drugs are available to treat COVID-19. The antiviral drug remdesivir was approved in May for emergency use in severely ill patients, and a study last month said the steroid dexamethasone reduced deaths in critically ill patients.
The experimental Regeneron drug, backed by the government’s “Operation Warp Speed” program to boost development of COVID-19 treatments and vaccines, is similar to an approach already tried at UW Health and elsewhere: infusing patients with blood from recovered donors.
That approach, known as convalescent plasma, uses antibodies — immune system proteins that help the body fight infection — from the plasma of people who have fought off COVID-19 to help people struggling with it.
Convalescent plasma generally uses all of a donor’s antibodies, while the experimental Regeneron drug purifies two antibodies considered to be most potent, Hartman said.
The supply of convalescent plasma is limited, and donor and recipient blood types must match. The antibody drug could always be available and wouldn’t require blood type matching, Hartman said.
“That seems to be a big advantage over something that is donor dependent,” said Hartman, who said he has no financial relationship with Regeneron.
However, convalescent plasma has shown promise as a treatment, he said. UW Health has used it on 40 COVID-19 patients, most of whom have done well.
In a study of the first 31 patients — 16 with severe disease and 15 with more serious life-threatening disease — four with life-threatening disease died. Among those with severe disease, all but one avoided the need for intensive care and ventilation.
Most patients required less medical support, such as coming off ventilators, about a week after transfusion, according to the “preprint” study, published online last month.
A larger study involving patients nationally is expected to be published soon, Hartman said.
Unless or until drugs like Regeneron’s are approved, “plasma is going to be a mainstay therapy for a while,” Hartman said.
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©2020 The Wisconsin State Journal (Madison, Wis.)
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