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Coronavirus treatment drug UF Health helped develop gets emergency FDA apporval

Study finds patients given remdesivir recover 4 days faster

GAINESVILLE, Fla. – Federal regulators on Friday allowed emergency use of an experimental drug that clinical trials, including some conducted the University of Florida, appears the first drug shown to help patients recovered from COVID-19.

The Food and Drug Administration acted after preliminary results from a government-sponsored study showed that Gilead Sciences’s remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients.

More than 230,000 people worldwide have died of complications of coronavirus.

This is the first study that involved UF Health showed a clear benefit to patients suffering from coronavirus complications, according to UF researchers. Remdesivir is not yet FDA approved but the principal investigators of the test sites at UF Health say the drug will now be standard of care for the treatment of COVID-19.

Patients treated with a placebo spent an average of 15 days in the hospital where patients treated with remdesivir spent an average of 11 days in the hospital. The study also shows the mortality rate from a COVID-19 infection dropped from 11.6% to 8% among those given the drug.

Talk turned to how quickly the federal Food and Drug Administration might act on remdesivir, being developed Gilead Sciences.

“You do now have a drug that you have proven can actually work on the virus,” the National Institutes of Health’s Dr. Anthony Fauci told The Associated Press.

In a separate study, researchers at the UF’s College of Pharmacy found mixed results with two drugs touted as potential treatments for COVID-19.

The study looked into the safety of using Lupus drug Hydroxychloroquine and azithromycin.

Researchers investigated reports from the FDA’s Adverse Reporting System – to see if the use of both drugs together led to serious arrhythmias that can lead to death.

“These very serious arrhythmias that can lead to death seem to be more of a concern with the azithromycin component of that combination,” said Dr. Joshua Brown, assistant professor at the UF College of Pharmacy. “We could generally conclude that at least for this adverse drug event. hydroxychloroquine don’t seem to necessarily increase the risk. But that doesn’t necessarily mean that we, we should be using the drug overall.”

UF launches program to determine how quickly to reopen campus

The encouraging news comes as the University of Florida is rolling out plans for a rigorous “test-and-trace” program to support the staged reopening of the UF, a large data-driven effort that will allow students, faculty and staff to return to campus as safely as possible while minimizing the risk of infection from the novel coronavirus

UF Health infectious disease specialists point out that scientific evidence and modeling show that new infections can be controlled and reduced to manageable levels by expanded testing and then quickly isolating those who are infected by the coronavirus.

Teams of UF epidemiologists also will stand ready to immediately trace the contacts of any member of the university community who tests positive for COVID-19, the disease caused by the coronavirus. Testing will be conducted on these contacts, and they, too, will be isolated if they are found to carry the coronavirus.

UF Health is setting up what is essentially a free-standing public health disease surveillance unit operating in collaboration with and under the authority of the Florida Department of Health.

UF leaders say the approach guides decisions that will be grounded in science.

“We are following public health principles that have long proved to be effective in mitigating the spread of infectious disease,” said David Nelson, M.D., senior vice president for health affairs at UF and president of UF Health. “We are not helpless in the face of the coronavirus. We can begin to return to our classrooms and our offices and our laboratories. But we need to do so smartly and with an eye toward protecting the most vulnerable among us.”

To that end, over the course of the next several months UF Health will be expanding testing to a wider array of people in the university community, including those who are asymptomatic but might be carriers of coronavirus, UF Health officials say, with more information to come soon.

A critical component of testing is the quick return of results, typically 12 hours or less for tests conducted and processed by UF Health. That allows for individuals who test positive to be quickly quarantined and their interactions with others investigated.

Contact tracing is a concept as old as the study of infectious disease. It involves some basic detective work and time-tested principles of epidemiology.

Students, faculty or staff who test positive for coronavirus will be interviewed by UF Health personnel trained in epidemiology or public health to identify as many of their recent contacts as possible. Roommates. Boyfriends or girlfriends. Acquaintances. The mechanic who fixed their car. A landlord who collected the rent. And so on.

One study shows that if 20% or more of the contacts of a symptomatic person are traced and put into quarantine, then an epidemic can be controlled and the chances of a “second wave” can be reduced significantly.

Not only will test-and-trace allow for the staged reopening of UF over the coming weeks, the data and experience can be a resource for the entire State University System.

At some point, antibody testing might also be of use to identify those who have already been exposed to the coronavirus. But antibody testing is not as simple as it sounds and there is still uncertainty about its usefulness, as there is reason to believe that just because someone has antibodies does not mean they cannot get or spread the infection again at some point in the future.

To be sure, as social distancing and stay-at-home orders are relaxed, there invariably will be an increase in cases of COVID-19. While the numbers of infected Floridians will decline as long as social distancing is in place, new cases will occur as those rules are relaxed. It is clear, said Lauzardo, the risk of infection will not entirely disappear.

Indeed, tighter social distancing might resume on campus if the number of coronavirus cases increases to a certain level.

A key to reopening UF is that UF Health Shands Hospital is well-positioned with supplies and patient capacity to treat anyone who requires hospitalization.

While few cases would be anticipated on campus with an aggressive test-and-trace program in place, it is important that the health system remain vigilant, health leaders say.

Numbers provide cause for optimism. In Florida, as of April 21, no Florida resident under the age of 25 has died from COVID-19.

University officials also are exploring options for the most vulnerable individuals to continue to social distance and have the option of working or taking classes online. That may include those over the age of 65 or anyone with underlying health conditions that make them particularly susceptible to a severe case of COVID-19, such as heart disease or diabetes.

“The goal of test and trace is not to prevent all cases of COVID on campus — that is impossible — but to slow the spread and to allow us to protect the most vulnerable and to prevent the hospital and health care system from becoming overwhelmed,” said Lauzardo.


About the Author
Kelly Wiley headshot

Kelly Wiley, an award-winning investigative reporter, joined the News4Jax I-Team in June 2019.

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