Christine Jordan Sexton
University of Florida Health is looking for up to 200 people willing to participate in a national study aimed at learning whether three currently available over-the-counter drugs can help people manage COVID-19 symptoms and prevent hospitalizations.
Initially, the university and One Florida + Clinic Research Network will study the effectiveness of fluticasone, an inhaled steroid commonly used to treat asthma and chronic obstructive pulmonary disease; fluvoxamine, a drug prescribed to treat depression; and ivermectin, an anti-parasitic drug in the form of a pill prescribed to treat people with infections caused by some parasitic worms.
Some people began using the veterinary form of ivermectin, even though there’s no strong clinical evidence it works. Worth noting: The ivermectin being tested in the ACTIV-6 study is an FDA-approved form of the drug for use in humans.
Study volunteers must be at least 30 years old, have tested positive for COVID-19 and have suffered, for less than seven days, from two or more mild COVID-19 symptoms. COVID-19 symptoms can include fatigue, shortness of breath, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal congestion or loss of sense of taste. The university hopes to enroll in the study people of color who have been disproportionately impacted by the virus, as well as those who live in rural areas.
The study is one of several research projects nationwide that are part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines, or ACTIV, public-private partnership funded by the National Institutes of Health. In all, researchers hope to enroll 15,000 participants nationwide.
UF Health will participate in the ACTIV-6 study, which explores how effective drugs approved by the U.S, Food and Drug Administration for other conditions are for COVID-19.
Elizabeth A. Shenkman, chair of the department of health outcomes and biomedical informatics in the College of Medicine at UF and co-principal investigator of the OneFlorida+ Clinical Research Network, said the goal is to identify drugs that can help people feel better faster and keep them out of the hospital.
Shenkman serves as the UF Health site principal investigator for ACTIV-6. Christina Li, an assistant professor in the UF College of Medicine’s division of internal medicine, serves as the UF Health physician site principal investigator.
The drugs researchers will be testing already have proven, in preliminary studies, to be somewhat effective against the COVID-19 virus, Shenkman said in a prepared release announcing the study.
“The only way to confirm that these drugs are safe and effective for treating the symptoms of COVID-19 is with a large, controlled clinical research study,” Shenkman said. “We hope ACTIV-6 will offer scientifically rigorous, definitive results.”
Participants will be assigned randomly to either receive a placebo or one of the three over the counter drugs being reviewed. Participants will be asked to record their symptoms in diaries and to respond to questionnaires either online or over the phone. Participants will receive shipments of the over-the-counter drugs to their homes.
Study participants also will be asked whether they are experiencing any long-term COVID-19 symptoms three months after the study is launched.
Researchers, meanwhile, will be monitoring participant hospitalizations and deaths over a 28-day period.
The Duke Clinical Research Institute in Durham, North Carolina, serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center in Nashville, Tennessee, as the study’s data coordinating center.
For more information, visit the ACTIV-6 Study website.
One comment
tom palmer
December 11, 2021 at 4:52 pm
That’s how these treatments should be studied rather than at web-based conspiracy theories.
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