Magazine

USF Health Leads Clinical Trials, Seeking Medication Treatment Protocols, Treatments, Cure

– USF RESPONDS: COVID-19 –

THROUGHOUT THE MONTH OF APRIL, USF Health researchers launched several clinical trials as part of the worldwide effort to reduce the severity of illness and even prevent COVID-19.

In connection with Tampa General Hospital, USF Health researchers are leading the examination of a range of medications and treatment protocols that could impact the disease at a symptoms level for patients and at the cellular level of the virus.

“The USF Health Office of Clinical Research and supporting parties are making strides that we’ve never made before,” says Rachel Karlnoski, PhD ’07, director of Clinical Research Operations for USF Health.

“The typical start-up timeframe for new clinical trials in an academic medical center is 90 days or more. Our goal for COVID-19 trials was five days or less and we have succeeded. Communication, collaboration and prioritization from our budget and contract analysts, onsite legal counsel, USF Institutional Review Board, central IRBs, investigators, study teams and regulatory managers have enabled our success.”

The united, expedited efforts paid off and now USF Health and TGH are conducting multiple front-line studies that link to larger efforts across the country, all in sync for finding treatments and cures for COVID-19.

In addition, there are several COVID-19 translational research projects taking place across USF Health.

The work may contribute to worldwide efforts to accelerate the discovery and validation of new technologies to diagnose and prevent the spread of SARS-CoV-2, as well as finding potential new treatments for COVID-19, the respiratory disease caused by the new coronavirus.

The studies are being conducted by scientists across disciplines including biochemistry, infectious diseases and international medicine, medical engineering, nursing, pharmacy, public health, structural biology and virology. The ambitious translational research initiative supplements the joint clinical trials launched last month by USF Health and Tampa General Hospital.

“Many fundamental questions remain about this newest coronavirus, including how it functions, the ability of antibodies to convey immunity, and whether genetic differences in certain populations affect their susceptibility to COVID-19 infection or severity of the illness,” says Dr. Stephen Liggett, associate vice president of the USF Health Office of Research and vice dean for research in the Morsani College of Medicine. “Our faculty and student researchers have been quick to mobilize their talent and resources, because they want to do whatever they can to find answers — both to help fight this pandemic and to prepare for future outbreaks.”

Clinical trials

One of the overarching research efforts is the inclusion of data related to COVID-19 as part of a national registry tracking many aspects of the virus and those infected with it, such as pregnant women and their babies. USF Health and TGH providers are actively submitting information to this registry.

Additional clinical trials looked at treatment options, including sarilumab to determine effectiveness in blocking inflammation in the lungs in hospitalized severely ill patients; remdesivir, an antiviral drug that may help kill the virus; hydroxychloroquine for severely ill patients as treatment, for health care workers as prevention, and for outpatient treatment in those who are not severely ill; and Ruxolitinib in critically ill patients to determine the impact of the medication in easing or stopping the associated cytokine storm, when the patient’s immune system becomes overwhelmed and attacks healthy cells.

Teams are also studying convalescent sera/plasma from people who have recovered from COVID-19 in those who currently have the disease.

Other studies are looking into ways for treating pneumonia associated with so many cases of patients with COVID-19; assessing the safety and anti-coronavirus response of combined suppression of host nucleotide synthesis in hospitalized adults with COVID-19; and testing Brequinar, an antiviral drug for treating COVID-19.

Translational research

Among the new translational research projects underway, or being scaled up, are: antibody tests and immunity; susceptibility in different ethnic backgrounds; protective antibodies and vaccines; portable biomedical testing system; and targeting viral replication.

Some of the COVID-19 related projects build upon the knowledge and insights USF Health scientists have acquired using advanced technologies to study the underlying molecular and cellular biology of other viruses and pathogens, including respiratory syncytial virus and HIV.

- SARAH WORTH ’86 | USF Health