A study testing experimental antibody drugs for infection with the novel coronavirus (Covid-19) had to be suspended a second time. Currently, discontinuation is carried out to investigate possible safety issues in patients who are hospitalized.
Pharmaceutical company Regeneron Pharmaceuticals Inc. said that independent monitors had recommended delaying enrollment of seriously ill patients, such as those requiring intensive oxygen care or a ventilator. That’s because there are potential safety concerns and an unfortunate balance of risks and benefits.
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Studies can continue to test two-antibody drug combinations in hospitalized patients who need little oxygen or no extra oxygen support. Other studies on Covid-19 patients who are mild or moderately ill are also continuing.
Antibodies are proteins made by the body when an infection occurs. Antibodies will stick to the virus and help it to be destroyed.
However, it can take several weeks for the most effective antibodies to form. Experimental drugs aim to immediately help by supplying a concentrated version of one or two of the antibodies that work best against the novel coronavirus (SARS-CoV-2) that causes Covid-19 disease in laboratory and animal tests.
Earlier this month, a different group of monitors recommended discontinuing enrollment in a United States (US) National Institutes of Health study testing the antibody drug Eli Lilly. It is aimed at investigating possible safety issues in hospitalized patients.
Earlier this week, the US National Institutes of Health (NIH) said no safety concerns had been verified. However, the institute stopped the research because the drug didn’t seem to work in the situation.
“These kinds of results tell us about the timing of their usefulness,” said Myron Cohen, a University of North Carolina virologist who also advises the US Government on Covid-19 treatment.
Animal testing has shown that antibody drugs work best when given early in the infection to reduce viral load. When someone is seriously ill, the medication may not help, but it’s too early to know if that’s the case.
Doctors already know that timing can be an issue in treating Covid-19. Studies show that dexamethasone and other steroids can lower the risk of death when given to very ill patients to impair an overactive immune system, but may be dangerous for those with only mild illness.
Pharmaceutical companies such as Lilly and Regeneron have asked the US Food and Drug Administration (FDA) to allow emergency use of the experimental antibody drug they are developing for patients with mild and moderate illness who do not require hospitalization. US President Donald Trump also received the drug Regeneron when he tested positive for Covid-19 earlier this month.
Regeneron said he would share advice from independent monitors with the FDA and the leaders of a separate UK study testing the drug in hospitalized patients.
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