DETROIT — Clinical trials are underway at two hospitals in Michigan for the cocktail of monoclonal antibodies that President Donald Trump has credited for his quick recovery from COVID-19.
Grand Rapid’s Butterworth Hospital and Beaumont-Royal Oak Hospital are studying the treatment developed by Tarrytown, New York-based Regeneron Pharmaceuticals. The drug REGN-COV2 contains two potent, complementary virus-neutralizing antibodies. The synthetic antibodies were created in the laboratory to specifically target the SARS-CoV-2 virus that causes COVID-19.
“It’s an interesting approach, and we think it’s potentially a very useful approach,” said Dr. Matthew Sims, director of infectious diseases research at Beaumont Health.
“Obviously, there’s a lot of interest in this study because President Trump got this drug … and he credits it with helping him and curing him. But right now he’s just one person, and we don’t know — without it he might have done just as well. We don’t know that; that’s why we have to do these studies.”
Trump received a dose of REGN-COV2 after doctors at Walter Reed National Military Medical Center requested authorization through the Food and Drug Administration’s expanded access, or “compassionate use” process, which allows individuals to be given investigational treatments outside of clinical trials if their condition is immediately life-threatening and no other treatment is available.
Trump also was given steroids as well as remdesivir, an antiviral medication granted emergency use authorization by the FDA on Oct. 22, becoming the first FDA-approved COVID-19 treatment.
Experts say it’s impossible to know whether the steroids, the remdesivir or the monoclonal antibodies cured the president because he received multiple treatments at the same time.
According to scientists, the only way to judge the safety and effectiveness of a new treatment is through randomized controlled clinical trials, where patients receive either the medication or a placebo, and neither researchers nor participants know what they got.
The trials will test the effectiveness of REGN-COV2 on hospitalized coronavirus patients, those who are not hospitalized, and also on people who have been exposed to the virus but have not yet tested positive.
Butterworth already is enrolling patients hospitalized with COVID-19, as well as patients who have the virus but are recovering at home. Beaumont-Royal Oak has not yet begun administering the drug, but hopes to begin enrolling hospitalized patients in the coming weeks, Sims said.
Spectrum Health Research Physician Dr. Gordana Simeunovic said the Regeneron trials are among several COVID-19 related clinical trials underway at the health system.
Among those is treatment with convalescent plasma made from the blood of a previously infected person who has developed antibodies to the virus.
While that treatment appears promising, Simeunovic thinks Regeneron’s monoclonal antibody treatment could potentially be more effective. She noted that the first FDA-approved treatment for Ebola consisted of monoclonal antibodies made by Regeneron.
“Convalescent plasma, the whole project is challenging because it is very difficult to determine the level of antibodies,” she said. “Monoclonal antibodies are a step forward.
“They are made artificially, but they do exactly the same job. … They give the body more time to develop antibodies.”
Regeneron’s first preliminary data published Sept. 29 showed that no unexpected safety findings were reported and that REGN-COV2 reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients.
“There are many clinical trials underway, there are multiple options that we are investigating,” Simeunovic noted. “There are good signals that we drugs might be working, but none of these are approved treatments other than remdesivir.
“There is a long way ahead of us, a lot of things to do to learn what is working and the best way to use all these therapies.”
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