AP – For the second time, a trial that tested an experimental antibody drug for COVID-19 was halted to investigate a possible safety issue in hospitalized patients.
Regeneron Pharmaceuticals Inc. said on Friday that independent monitors have recommended suspending enrollment of patients with the most severe illnesses – those in need of intense oxygen therapy or ventilators – because of potential safety and weight issues. equal to the disadvantage between risks and benefits.
The study may continue to test a combination of two antibody drugs in hospitalized patients who need little or no extra oxygen, the monitors said. Further studies in people with mild to moderate illness are also continuing. US President Donald Trump took the drug Regeneron when he was sick earlier this month.
Get The Times of Israel̵7;s Daily Edition by email and never miss our top stories Subscribe Free
Antibodies are proteins that the body makes during an infection; they attach to a virus and help it be removed. But it can take several weeks to develop the most effective ones. The experimental drugs are intended for immediate help, by providing concentrated versions of one or two antibodies that work best against coronavirus in animal and lab tests.
Earlier this month, another monitoring group recommended suspending enrollment in the US National Institutes of Health study to test an antibody drug Eli Lilly to investigate a possible safety issue. out in hospitalized patient. On Monday, the NIH said no safety issues had been verified, but they stopped the study because the drug did not appear to work in that situation.
“These types of results tell us about the duration of the benefit,” said Dr. Myron Cohen, a virologist at the University of North Carolina who advises the government on COVID-19 treatments.
Animal tests show that antibody drugs work best when taken early in the event of an infection to reduce the amount of virus in a patient’s body, he said. Once someone is seriously ill, the medicine may not help, but it is too early to know if that is the case, he added.
Doctors already know that timing can be important when it comes to COVID-19 treatments. Studies show that dexamethasone and other steroids can reduce the risk of death when given to critically ill patients to suppress the immune system to over-function, but they can be harmful to those who are just sick. light.
Lilly and Regeneron have asked the Food and Drug Administration to authorize the emergency use of their experimental antibody drugs for patients with mild to moderate illnesses that do not need hospitalization.
Regeneron said it will share advice on Friday from independent monitors with the FDA and leaders of a separate UK study testing their drugs on hospitalized patients.