Tampa General Hospital and USF Health will serve as a site for one of the nation’s biggest clinical trials to determine if any of three medications, including ivermectin, are effective in treating COVID-19.
Called ACTIV6, the study is backed by the National Institutes of Health (NIH) and led by Duke University’s Adrian Hernandez. Principal investigator for the USF Health/TGH site of the study is Dr. Jason Wilson, associate professor in the USF Health Morsani College of Medicine and associate medical director of the ER at Tampa General.
“Research is a critical component of our vision to become the nation’s most innovative academic health system,” said John Couris, president and CEO of Tampa General Hospital. “Through research and innovation, we’ll determine how we can most effectively treat COVID-19 while mitigating serious complications and death. We’re proud to partner with NIH and USF on this important effort.”
The double-blind study is examining the repurposed use of three drugs when used to treat COVID-19: ivermectin, fluticasone furoate and fluvoxamine. These repurposed medications are drugs already approved by the U.S. Food and Drug Administration (FDA) for use in humans for other diseases, but not yet approved for the treatment of COVID-19. Tampa General will host 100 participants. Nationwide, the study will recruit and treat 15,000 participants.
To be eligible for the ACTIV-6 study, participants must be age 30 or older, have tested positive for COVID-19 within the past 10 days, and have at least two known COVID-19 symptoms for seven days or less.
Ivermectin gained national attention as individuals began to use the antiviral to reduce the symptoms of COVID-19. The form intended for humans is safe and commonly used to kill parasitic infections and other illnesses. However, the FDA received multiple reports of people who needed medical attention and hospitalization after taking the form of ivermectin intended for livestock.
The Florida Poison Control Center said it treated 121 ivermectin-related cases across the state last year, more than six times the number of cases in 2020.
Fluticasone furoate is an inhaled corticosteroid that helps to relieve asthmatic symptoms. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that is intended for the treatment of obsessive-compulsive disorder (OCD) and depression.
Results from the study will help researchers understand how existing medications can improve symptoms and reduce hospitalizations for patients with COVID-19. Although all three drugs have not been approved by the FDA to treat COVID-19, if proven effective against the virus, they could help to alleviate the burden on the nation’s health care industry.
“We are committed to expanding access to affordable, high-quality care across the state of Florida,” said Couris. “This study is one part of our goal. Through the hard work of our team members, we are working toward finding additional safe and effective treatments for COVID-19. We are grateful for our partnership with the University of South Florida and the National Institute of Health’s Accelerating COVID-19 Therapeutic Intervention and Vaccines.”
To learn more about this study, visit the ACTIV6 website here.