The Food and Drug Administration has not approved Regeneron for regular use among COVID-19 patients. The president received the treatment under “compassionate use” provisions, when an experimental medicine is provided on a case-by-case emergency basis, while studies of it continue.
Three clinical trials are underway at Colorado’s Anschutz Medical Campus to evaluate the Regeneron antibody treatment for COVID-19. President Donald Trump received the experimental drug cocktail at the White House on Friday before he was taken to Walter Reed National Military Medical Center.
Dr. Thomas Campbell, a University of Colorado School of Medicine and UCHealth infectious-disease specialist, is leading the Colorado site in two multi-center clinical trials sponsored by Regeneron. The trials focus on testing the drug with outpatients as well as inpatients.
The new drug is in late-stage testing and its safety and effectiveness are not yet known. No treatment has yet proved able to prevent serious illness after a coronavirus infection.
Campbell said the results of the clinical trials are “encouraging,” but cautioned that Regeneron had yet to publish detailed, peer-reviewed data.
“We don’t know if those measures have any clinical significance, bottom line,” he said. “You would think that they would, and you would think that they could correlate not only with getting people better faster by reducing the viral load in respiratory secretions but also that it would decrease the transmissibility – so reduce the infectiousness of the individual who has COVID and prevent spread to other people.”
A third study is considering Regeneron’s effectiveness in preventing COVID-19. The trial is being led by Dr. Eric Simoes and Dr. Brian Montague at CU School of Medicine.
How Antibodies Work
Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help the immune system eliminate it. Vaccines trick the body into thinking there’s an infection so it makes these antibodies.
But it can take weeks for them to form after natural infection or a vaccine. The drugs aim to give that protection immediately, by supplying concentrated versions of one or two antibodies that worked best against the coronavirus in lab and animal tests.
Regeneron’s drug contains two antibodies to enhance chances that it will work. The company previously developed a successful Ebola treatment from an antibody combo.
The drug is given as a one-time treatment through an IV. In multiple studies, Regeneron is testing it both for preventing infection and in people already infected, like President Trump, to try to prevent serious illness or death.
Regeneron said partial results from about 275 COVID-19 patients who were not sick enough to need hospitalization suggested it might be cutting how long symptoms last and helping reduce the amount of virus patients harbor.
However, the study has not been completed, the results were only announced in a company news release and have not been published or reviewed by other scientists.
