ECU COVID-19 clinical trial receives FDA emergency use authorization

GREENVILLE, N.C. (WTVD) -- The United States received a second dose of good news this week when drug manufacturer Eli Lilly announced a COVID-19 antibody treatment received emergency use authorization from the FDA.

The study was done using monoclonal antibodies for outpatient persons at East Carolina University in Greenville.

"Encouraging and promising are two good adjectives," said ECU infectious diseases expert Dr. Paul Cook.

The clinical trial found itself to be effective for people who were experiencing mild novel coronavirus symptoms, however, not sick enough to be admitted to the hospital.

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Speaking to the efficacy of the antibody treatment, Dr. Cook said, "For those individuals, now we have something that will likely keep them from developing worse disease as such they have to go to the hospital."

In mid-October, a clinical trial involving inpatients using the same antibody treatment drug was paused for health and safety concern "out of an abundance of caution".

"The outpatient data looks very promising," said Dr. Cook. "Same drug. Didn't work in the hospital setting. Does work when given early in the course of the illness."

In a press release issued by the FDA, Patrizia Cavazzoni, M.D., acting director of the FDA's Center for Drug Evaluation and Research, said, "The FDA's emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients. We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available."

The emergency use authorization (EUA) will be reserved for people considered to be high-risk. This group includes people aged 65 and up, the obese, those with heart and/or severe lung conditions, and people with diabetes.

Dr. Cook said of the treatment, "It has to be done in places where there's a lot of oversight and that people are comfortable doing infusions. The infusions itself takes an hour. Persons have to be monitored for an hour afterward.

At this time, it has yet to be announced specifically when the treatment will become available. Dr. Cook stopped just short of promising a date but said the limited supply of doses could come as early as this week.
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