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New results from a multi-phase clinical trial show that a cocktail of special antibodies can reduce the risk of developing symptomatic COVID-19 by 81 percent if someone is not already infected with the virus. And for those who do become infected, the drug can help clear the virus from their body more quickly and shorten the duration of their symptoms.
Dr. Anita Kohli, director of research for Arizona Clinical Trials and investigator for the Eli Lilly and Regeneron trials, at a monoclonal antibody clinical trial center in Mesa, Ariz., Wednesday, Aug. 12, 2020. ADRIANA ZEHBRAUSKAS NYT |
In another trial it was found that the cocktail, called REGEN-COV, is also capable of reducing by 76 percent the chances that people will develop coronavirus symptoms if it is an asymptomatic infection after three days, according to the announcement. Monday the American biotech company Regeneron.
The Food and Drug Administration (FDA) authorized the cocktail's emergency use in November , and it is currently used to treat mild-to-moderate COVID-19 in adults and children at least 12 years of age who are at high risk of disease. serious and that they are not hospitalized; It was the same drug that former President Donald Trump was given when he tested positive for coronavirus in October .
Researchers claim that these antibodies can help protect people from infection and disease in conjunction with vaccines, and may be particularly helpful for those who are waiting to receive their vaccines or for those with compromised immune systems that might not respond well to vaccines.
"With more than 60,000 Americans still being diagnosed with COVID-19 each day, the REGEN-COV antibody cocktail could help provide immediate protection to unvaccinated individuals who are exposed to the virus," said Dr. George Yancopoulos, President. and Regeneron's chief science officer, in a statement. "These Phase 3 data provide even more evidence that REGEN-COV ... can change the course of COVID-19 infection in outpatients," by effectively preventing asymptomatic patients from becoming symptomatic.
Participants in the late-stage trial were enrolled only if they did not have any COVID-19 symptoms, had no coronavirus antibodies, and were living with someone who had tested positive in the past four days. People who tested negative were assigned to the "prevention trial" (1,505) and those who tested positive were put into the "treatment trial" (204).
All participants were randomly given a dose of the antibody cocktail or a placebo by subcutaneous injection , which is when a short needle introduces the drugs into the layer of tissue between the skin and the muscle. This technique is typically used when drugs are given in small doses or need to be given quickly.
Vaccines against COVID-19, for example, are administered intramuscularly.
In addition to finding that the antibody cocktail reduced the risk of developing symptomatic infections by 81 percent in people who were not infected, the trial found that the drug helped clear symptoms in one week, compared to three weeks in the previous week. placebo group, in those who did develop infections.
"These results are very encouraging and suggest that REGEN-COV is very effective in preventing symptomatic COVID-19 in household contacts of people infected with SARS-CoV-2," co-investigator Dr. Dan Barouch, said in the statement. principal of the trial and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. "The rapid and robust protection, along with the subcutaneous route of administration, support the practical utility of these antibodies to protect against COVID-19 in multiple settings, even after high-risk exposures."
Side effects occurred in 20 percent of the participants who received the cocktail and included fever, itchy skin, chills and abdominal pain. No one who received the drug was hospitalized. Two people who received the cocktail died, but their deaths were not caused by COVID-19 or the drug, according to the company.
The antibody cocktail was found to prevent people with asymptomatic infections from progressing to symptomatic by 76 percent after three days.
The researchers also found that the drug reduced the number of weeks patients experienced symptoms by 45 percent and lowered their viral load - the amount of virus in their body - by more than 90 percent. This means that people treated with REGEN-COV may be less likely to spread the virus once infected.
Side effects similar to those in the other trial occurred in 34 percent of the participants. No one was hospitalized or died.
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