UF Health enrolls first patient in COVID-19 trial
GAINESVILLE, Fla. (WCJB) - Doctors at the University of Florida moved to a new phase in their study to test a drug to examine if it can lessen the severity of the coronavirus.
UF Health enrolled its first patient in a clinical trial to treat COVID-19.
The clinical trial is the Regeneron Pharmaceuticals' monoclonal antibody cocktail. Monoclonal means the antibodies have been cloned from a single, ancestral cell.
Doctors will be giving the patient antibodies to research if the drug can neutralize the coronavirus and prevent it from infecting cells.
“Our hope is that this particular drug — particularly if we give it early in the infectious phase — will basically prevent people from developing serious clinical symptoms,” said Dr. Mark Brantly, a UF health principal investigator of the COVID-19 trial.
UF Health hopes to enroll at least 20 hospitalized patients who are sick or progressing to a critically ill state.
Brantly said if the antibodies block the coronavirus from binding to cells, it might reduce the viral load carried by an individual.
“We want to block all of the possible areas that might be sort of the ‘door-knocker’ that gets the virion into the cell,” Brantly said.
The infective form of a virus outside a cell is called a virion.
UF Health is one of hundreds of medical centers internationally participating in the blinded, placebo-controlled, randomized clinical trial.
Doctors will be using two lines of synthetic antibodies during the trial that have been tested in humans and animal models and have shown the most promise in being able to neutralize the virus.
According to UF Health, one line comes from laboratory mice whose immune systems have been genetically modified to mimic humans'. The second line is derived from humans who have previously been infected by COVID-19.
Brantly said during the SARS epidemic, scientists around the world took information from the virions and sequenced it and determined the protein structure of all of the components of it.
They took the information and made small areas of the protein and generated an antibody to those proteins.
“We would identify people that have COVID-19 and may have an increase in the amount of symptoms and then provide this drug to them,” Brantly said. “Hopefully, [it will] prevent anymore virions from being made, causing more lung disease and more disease in general.”
Brantly said the clinical trial is in Phase II and he briefly shared what each phase entails when doctors do drug development.
He said there are five phases in total and shared the steps leading up to Phase III.
The preclinical phase is when doctors test the drug in animals.
In Phase I, doctors give a limited number of individuals a drug to see if it is safe and/or helpful.
In Phase II, doctors expose the drug to a lot more patients and explore different drug concentrations.
In Phase III, the number of patients increase and they use the drugs they expected they might need for the study which is called the pivotal trial.
If the risk is lower than the benefit, the FDA might approve it.
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