A study has been temporarily stopped, after it was testing an experimental vaccine for antibodies to the Corona epidemic, in order to investigate a potential safety problem for hospital patients.
The pharmaceutical company, Regeneron, announced that independent observers had recommended suspending the registration of severely ill people (those requiring intensive oxygen therapy or ventilators), due to “a potential safety issue and an inadequate balance of risks and benefits.”
Observers said the study could continue to test the two-antibody combination of drugs on hospitalized patients who need little or no additional oxygen.
Other studies are continuing in people with mild or moderate symptoms, according to the Associated Press.
It is noteworthy that antibodies are proteins that the body makes when infection occurs and attaches to the virus and helps eliminate it. However, the most effective ones can take several weeks to form.
The experimental drugs aim to help with this right away, by providing concentrated copies of one or two antibodies, which work best against the Corona virus in laboratory and animal tests.
And earlier this October, a different group of observers recommended temporarily suspending registration in a study by the US National Institutes of Health to test the “Eli Lilly” antibody drug, in order to investigate a potential safety problem for patients in the hospital.
On Monday, the National Institutes of Health said that “no safety issue has been verified,” but that they have discontinued the study because the drug does not appear to work in this situation.
“These kinds of results tell us about the timing of the benefit,” said Dr. Myron Cohen, a virologist at the University of North Carolina, who advises the government on treatments for Covid-19.
He explained that animal tests indicate that antibody drugs work better when given early in the infection, to reduce the amount of virus.
He added that once someone is seriously ill, these drugs may not help, “but it is too early to tell if this is the case.”
And he noted that animal tests revealed that antibody drugs work better when given early in the infection, to reduce the amount of virus.
And doctors already know that timing can be important when it comes to treatments for Corona.
Studies indicate that “dexamethasone” and other stimulants can reduce the risk of death when given to severely ill patients, to suppress an overactive immune system, but it may be harmful to those with mild disease.
Regeneron said it plans to share Friday’s advice from independent observers, with the US Food and Drug Administration and the leaders of a separate UK study, testing its drug on hospitalized patients as well.
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