THURSDAY, Oct. 29, 2020 (HealthDay News) — An Eli Lilly-developed COVID-19 antibody drug that didn’t help hospitalized patients might still prove effective in treating people with mild or moderate infections, new clinical trial data suggests.
The U.S. National Institute of Allergy and Infectious Diseases pulled the plug earlier this week on a clinical trial aimed at people hospitalized with COVID-19 — not because of any safety problem, but because the drug wasn’t showing any real benefit to them.
However, another clinical trial has shown that the antibody drug might be useful in keeping people with mild or moderate COVID from getting worse, according to results in the Oct. 28 issue of the New England Journal of Medicine.
The drug, currently named LY-CoV555, appeared to keep more mild and moderate patients from needing the emergency room or hospitalization. Only 1.6% of folks who received the antibody drug landed in a hospital, compared with 6.3% of patients who received a placebo.
Researchers also report that people who received the drug had slightly less severe symptoms than those in the placebo group.
“This is an opportunity now for those who are early in the process of the infection to get a treatment and really stem the course of the disease and try to prevent people from getting worse,” said lead researcher Dr. Peter Chen. He’s director of the division of pulmonary and critical care medicine at Cedars-Sinai Medical Center in Los Angeles.
COVID-19 researchers have been looking for medicines that could act much like Tamiflu does in flu patients — catching the infection early and preventing it from progressing to a life-threatening state.
“A key tool that we desperately need in the fight against COVID-19 is a countermeasure to prevent people from requiring hospitalization,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore. “If monoclonal antibodies can achieve this, they will be of great value.”
Lilly’s drug is derived from antibodies drawn from a COVID-19 survivor, Chen said.
“They pulled this out of a person who recovered from COVID, and they found the antibody that the human body made,” Chen said. “It’s been worked over by the human immune system so that it really has been fine-tuned to be specific for the virus.”
A similar, two-antibody cocktail from Regeneron Pharmaceuticals Inc. was given to U.S. President Donald Trump on an emergency basis when he was sickened with the coronavirus. Earlier this month, former New Jersey Gov. Chris Christie said he had received Lilly’s experimental treatment shortly after his COVID diagnosis.
Pulling the plug
The U.S. government was right to pull the plug on trials aimed at helping hospitalized patients, because the data showed no real benefit, said Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group.
“That’s an aspect of clinical trial design that is particularly pertinent in the ‘need for speed’ with COVID. Why continue a trial for six months or a year only to find there’s no benefit?” Poland said.
But there are a number of clinical trials ongoing for the Lilly drug aimed at different groups who might benefit from antibody treatment, Chen said.
The new clinical trial randomly assigned 452 patients to receive a single IV infusion of the antibody drug at one of three different doses, or to receive a placebo.
Only one of the doses appeared to accelerate the body’s ability to kill off the coronavirus, but Chen said that’s likely related to the study’s design. The clinical trial was set to assess viral load at day 11. Only afterward did the researchers realize that by that time nearly all mild or moderate
COVID patients have pretty much licked their infection.
However, the researchers did find that treatment with any dose of the drug reduced a person’s symptoms and risk of hospitalization.
Both Regeneron and Eli Lilly have applied for Emergency Use Authorizations for their antibody drugs, Chen said.
Still, more studies are needed
But Poland believes it will take more research to prove that Lilly’s drug provides a significant benefit for people with mild or moderate COVID.
“You have to enroll a lot of people with mild disease, only a fraction of which are going to get bad enough to go into the hospital, in order to test the hypothesis that it reduces hospitalization,” Poland said. “That’s a much bigger and more difficult trial.”
Part of the problem is figuring out who should receive the antibody infusion. Right now, health risk factors such as age, obesity, lung disease or smoking are the only indication that someone might have a higher chance of their mild COVID turning worse, Poland and Chen said.
“What’s really hard is we can’t peer into the future and see who are the ones who are going to end up in the hospital and the ICU,” Chen said. “We can only go by risk factors.”
Until medical science uncovers some other sign that a person is at greater risk from COVID, it’s going to be hard to figure out who should get this antibody treatment, Poland and Chen said.
“There’s always going to be a limited amount of this drug available. With these biologics, you can only manufacture so much of it,” Chen said. “So you really need to save the doses for the people who have a higher chance of really having a benefit.”
More information
The U.S. Centers for Disease Control and Prevention has more about COVID-19 .
SOURCES: Peter Chen, M.D., director, division of pulmonary and critical care medicine, Cedars-Sinai Medical Center, Los Angeles; Amesh Adalja, M.D., senior scholar, Johns Hopkins Center for Health Security, Baltimore; Gregory Poland, M.D., director, Mayo Clinic Vaccine Research Group, Rochester, Minn.; New England Journal of Medicine, Oct. 28, 2020
