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This is the second suspension of trials of experimental antibody drugs against COVID-19 to investigate possible safety issues in hospitalized patients.
Regeneron Pharmaceuticals Inc. said on Friday that due to potential safety issues and the unfavorable balance between risks and benefits, the independent guardian recommends suspending recruitment of the most seriously ill patients-those who require strong oxygen therapy or ventilator therapy.
Monitors said the study could continue to test the drug combination of the two antibodies in hospitalized patients who need little or no additional oxygen. Other studies in mild or moderate populations are also continuing.
Antibodies are proteins produced by the body during infection. They will attach to the virus and help eliminate it. However, the most effective process may take several weeks to develop. These experimental drugs are designed to provide immediate help by providing one or two concentrated forms of antibodies that are most effective against coronavirus in laboratory and animal tests.
Earlier this month, another group of monitors recommended to suspend a study by the National Institutes of Health that tested Eli Lilly antibody drugs to investigate possible safety issues in hospitalized patients. The National Institutes of Health said on Monday that it had not confirmed the safety issue, but because the drug appeared to be ineffective in this case, they stopped the study.
Dr. Myron Cohen, a virologist at the University of North Carolina, said: “These results let us know when to benefit.”
He said that tests on animals have shown that antibody drugs are best given in the early stages of infection to reduce the number of viruses. He said that once someone is seriously ill, drugs may not help, but now it is too early to know if it is too early.
Doctors already know that for COVID-19 treatment, timing is important. Studies have shown that when dexamethasone and other steroids are used in critically ill patients to reduce the overactive immune system, they can reduce the risk of death, but may be harmful to those with mild illness.
Lilly and Regeneron have asked the Food and Drug Administration (FDA) to allow emergency use of experimental antibody drugs for mild and moderate patients in urgent need of treatment. Earlier this month, President Donald Trump received a regenerant drug when he was ill.
Regeneron said it will share Friday’s recommendations with the leaders of the U.S. Food and Drug Administration (FDA) and another study in the UK that conducted drug testing on hospitalized patients.
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