Tampa Bay is part of a nationwide study to examine the efficacy of three drugs to treat COVID-19, including ivermectin, the antiparasitic medication that some believe can cure the virus. Instead, it sent people to the emergency room.
The University of South Florida and Tampa General Hospital are participating in the National Institute of Health’s Accelerating COVID-19 Therapeutic Intervention and Vaccines public-private partnership, which brings together organizations and companies to study new COVID-19 treatments and variants. Launched last summer, the ACTIV-6 study looks at how three repurposed drugs respond to the virus:
- Fluticasone furoate, an inhaled steroid that treats asthma.
- Fluvoxamine, a selective serotonin reuptake inhibitor that treats obsessive-compulsive disorder.
- Ivermectin, used to treat infections caused by parasitic worms as well as head lice, rosacea and scabies.
Tampa General’s emergency room associate medical director, Jason Wilson, leads the USF Health/Tampa General study site. When an individual in Tampa Bay enrolls in the study online, a member of his team verifies their eligibility: They’re 30 or older, they’ve tested positive for COVID-19 within the past 10 days, and they’re experiencing at least two symptoms for seven days or less.
The team member then calls the participant to explain the process and mails them one of the three drugs, or a placebo. The team will call the participant daily during the week that the medication is administered to monitor their symptoms and answer questions, Wilson said.
The double-blind study — meaning neither the researchers nor the subjects know whether they’re using one of the drugs or the placebo — expects to enroll 15,000 participants nationwide. Wilson said he expects about 100 participants in Tampa Bay.
The repurposed drugs will not relieve common virus symptoms such as fever or runny nose, Wilson said. But evidence suggests they might prevent mild to moderate COVID-19 cases from progressing to the point of hospitalization.
“The goal is to clearly show that use of these medications decreases the number of people who end up in the hospital,” he said.
Current COVID-19 treatments for mild symptoms, such as antiviral infusions or monoclonal antibodies, require accessing a healthcare site. Certain monoclonal treatments are no longer effective against the omicron variant.
But the three drugs in the study are affordable and readily available, Wilson said, so if they prove effective against COVID-19, they could ease the pandemic’s burden on the healthcare system by allowing patients to recover at home.
“There is an interest in cheaper options rather than new designer drugs from pharmaceutical companies,” he said.
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Existing drugs enable production to easily scale up. Pfizer’s antiviral drug Paxlovid was approved by the FDA in December for at-home use but the company has struggled to meet demand as production increased.
Ivermectin has not been approved by the FDA to treat COVID-19. But for most of 2021, conservative politicians and pundits promoted ivermectin as a potential wonder drug, according to The Washington Post.
“There’s a perception that scientists and the government are ignoring cheap and accessible medications in favor of Big Pharma,” Wilson said. “ACTIV-6 clearly demonstrates that’s not the case.”
Ivermectin has been prescribed in poorer countries where vaccines were not available, The Post reported, and there were scant, reliable studies showing it worked. The FDA continues to warn Americans not to take the drug, due to reports of “patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.”
As demand for ivermectin rose, many started using a veterinary formulation for deworming livestock such as cattle and pigs.
Veterinary ivermectin is highly concentrated for large farm animals, which makes it easy for humans to overdose, said Justin Arnold, medical director at the Florida Poison Control Center in Tampa. Toxic exposure to ivermectin, he said, can lead to nausea, vomiting, dizziness, or in severe cases, deep confusion and coma.
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. The rate of toxic reactions last August led the FDA to tweet: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
Some Florida leaders, however, continue to endorse ivermectin, including Surgeon General Joseph Ladapo. In a Wall Street Journal op-ed he co-authored in November, the UCLA researcher promoted ivermectin as a home remedy for COVID-19.
An advisor to Gov. Ron DeSantis, California psychiatrist Mark McDonald, is another proponent of ivermectin. He called the drug an “effective, safe, inexpensive treatment” in an Aug. 5 Twitter post, and accused the FDA of withholding ivermectin because it had already spent billions of dollars to “mass vaccinate the population.”
In a statement to the Tampa Bay Times, DeSantis spokeswoman Christina Pushaw said the surgeon general is “doing an outstanding job for Floridians, and that includes gathering and conveying the most accurate, up to date information about the approved — as well as potential — treatment options for COVID-19.”
“The Governor believes Floridians should have access to treatments that work to lower the risk of serious illness and death from COVID-19,” Pushaw said.
Arnold said ivermectin should be taken only with a doctor’s prescription and guidance.
“Going through the ACTIV-6 trial is the appropriate way where patients can be safely monitored and we can assess a true response to the drug,” Arnold said.
Reliable studies take time, Wilson said, and those eager to try new treatments and skip the scientific process do more harm than good.
“We need to have safe, large, systemic ways to investigate treatments for COVID-19,” he said.
It’s too early to determine the impact that ivermectin could have on treating COVID-19. Wilson emphasized that vaccines still are the most effective way to prevent a severe virus infection.
He advises people to find the distinction between science and politics.
“Ivermectin has captured the public’s imagination since the beginning of the pandemic,” Wilson said. “Science is interesting in that it happens in the context of politics … but those binary views don’t really structure themselves in the actual science.”
You are eligible to join the ACTIV-6 study if:
- You are 30 years or older.
- You tested positive for COVID-19 in the last 10 days.
- You have had at least two COVID-19 symptoms for seven days or less: fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, and/or new loss of sense of taste or smell.
To learn more about the ACTIV-6 study, visit activ6study.org.
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How to get tested
Tampa Bay: The Times can help you find the free, public COVID-19 testing sites in Citrus, Hernando, Hillsborough, Manatee, Pasco, Pinellas, Polk and Sarasota counties.
Florida: The Department of Health has a website that lists testing sites in the state. Some information may be out of date.
The U.S.: The Department of Health and Human Services has a website that can help you find a testing site.
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How to get vaccinated
The COVID-19 vaccine for ages 5 and up and booster shots for eligible recipients are being administered at doctors’ offices, clinics, pharmacies, grocery stores and public vaccination sites. Many allow appointments to be booked online. Here’s how to find a site near you:
Find a site: Visit vaccines.gov to find vaccination sites in your ZIP code.
More help: Call the National COVID-19 Vaccination Assistance Hotline.
Phone: 800-232-0233. Help is available in English, Spanish and other languages.
Disability Information and Access Line: Call 888-677-1199 or email DIAL@n4a.org.
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More coronavirus coverage
OMICRON VARIANT: Omicron changed what we know about COVID. Here’s the latest on how the infectious COVID-19 variant affects masks, vaccines, boosters and quarantining.
KIDS AND VACCINES: Got questions about vaccinating your kid? Here are some answers.
BOOSTER SHOTS: Confused about which COVID booster to get? This guide will help.
BOOSTER QUESTIONS: Are there side effects? Why do I need it? Here’s the answers to your questions.
PROTECTING SENIORS: Here’s how seniors can stay safe from the virus.
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