RI completes largest monoclonal antibody trial in the nation

Coronavirus

EAST PROVIDENCE, R.I. (WPRI) — Nearly one year after one of the largest clinical trials for the Regeneron antibody cocktail began in Rhode Island, the doctor leading the study tells 12 News it has uncovered promising results.

Dr. Eleftherios Mylonakis, the Director of Infectious Disease at Brown University and the Lifespan hospitals, said Regeneron is now asking the U.S. Food and Drug Administration (FDA) to approve the use of its monoclonal antibody treatment for those hospitalized with the virus.

The FDA had previously granted emergency use authorization for the drug, but only for patients who didn’t require hospitalization.

Mylonakis led the local trial and said patients who did not have antibodies of their own responded well to the treatment.

“What we call ‘relative risk,’ the possibility of them going to mechanical ventilation or dying, was decreased by more than 50%,” he said. “Now for the people who have enough antibodies of their own, the treatment didn’t cause any harm but it also didn’t provide any benefit.”

Participants in the study received one of two dosage amounts of the drug, or a placebo.

Additionally, Mylonakis said Lifespan is now conducting a trial of Pfizer’s new oral medication for people who are infected with COVID, but not hospitalized.

“Hopefully we’re going to have something like a Z-pak or something similar like a Tamiflu for outpatients with COVID-19, and that would be another step towards a more normal society,” he said.

Pharmaceutical company Merck has its own version of an oral antiviral drug that they claim reduces the risk of death or hospitalization from COVID-19. The company plans on seeking FDA authorization for the pill as soon as possible.

Mylonakis said the more options for fighting the virus in its various phases, the better.

“Initially, when you see a complex problem, the human nature is that you start thinking about one simple [solution]: it was going to be the masks, it was going to be the warm weather, it was going to be the social distancing, even the vaccines turned out not to be the absolute solution. So, we need all available [approaches],” he said.

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