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For much of the latter part of 2021, Polk County Commissioner Neil Combee pushed to make ivermectin more widely available to patients sick with COVID-19.
Local health leaders pushed back against his messaging, saying the drug has adverse side effects, and that there isn’t enough evidence to prove it treats the virus.
Now, the county’s largest hospital system is putting ivermectin to the test — administering the parasite drug to COVID patients with mild to moderate symptoms as part of a nationwide study to determine its effectiveness.
Lakeland Regional Health has joined a study led by the National Institute of Health, the Duke University Clinical Research Institute and the Vanderbilt University Medical Institute that officially launched in June and aims to enroll nearly 15,000 participants across the U.S.
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In addition to ivermectin, the study is also testing to see if two other FDA-approved prescription drugs can combat COVID: Fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease; and Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), often prescribed for depression.
Timothy Regan, the hospital's chief medical officer, said in a statement that in order to be eligible for the study, participants must be 30 years of age or older, have had a positive COVID-19 test within the past 10 days, and have at least two symptoms of the illness for seven days or less.
“If the patient meets criteria for eligibility, they will be asked if they are interested in participating in the study and potentially being treated with one of the drugs,” Regan said in an email. "If so, they may select one of the specific arms, or they can be randomized to any one of the arms. As is typical with many studies, enrolling does not mean the patient will receive the drug, as they may receive a placebo.”
If the patient agrees to participate, the drug/placebo is sent to their home by the national pharmacies that Duke has contracted with as part of the study, Regan said. The hospital will not have the drug/placebo in the emergency room, and a patient would not be started on the drug in the ER, she added.
Patients will be made aware of the study only after they’ve presented to the ER for testing/treatment of symptoms, Regan said.
“Studies such as these are part of the scientific process to ensure that any drugs or devices that are used in patient care have been deemed as safe and effective for patient care on an ongoing basis,” Regan said in a statement. “Lakeland Regional Health is committed to advancing the science of medicine through such research studies, and we look toward continuing to bring innovative treatments and technology to the community we serve.”
On Wednesday, Regan said in an email to The Ledger that the ivermectin arm of the study was temporarily on hold “due to drug supply issues” and “not in response to any safety concerns.”
By Friday, Dr. Adrian Hernandez, the principal investigator for the study with Duke University Medical Center, told The Ledger that the ivermectin arm of the trial had been reinstated.
“It was simply a study drug distribution delay because enrollment for ACTIV-6 was faster than what we had originally forecasted,” he said in an email. “So there was a catch-up that was needed.”
As of Thursday, more than 2,000 people across the county were enrolled in the study.
Ivermectin, manufactured by Merck, has generated a lot of attention over the past year. There’s an animal form of the drug, used as a dewormer, that can be picked up at local feed stores. The human form of the medication is available only by prescription.
In Florida, Dr. John Littell, an family medicine physician from Ocala, told The Ledger in October that he writes between 30 to 40 prescriptions for the parasite drug per week for use against COVID.
A Times Magazine Investigation found that a Tampa-based pharmacy, with an office in Auburndale, has been doling out a high volume of ivermectin at a higher-than-normal price.
Locally, two Polk County Commissioners, Combee and Bill Braswell, have stated publicly that they’ve been taking ivermectin.
But national health leaders have discouraged the use of ivermectin against COVID. In August, the Food and Drug Administration Tweeted: “You are not a horse. You are not a cow. Seriously ya’ll, stop it.
Dr. Daniel Haight, Lakeland Regional’s Vice President of Community Health and Medical Director of Infection Prevention, told The Ledger in August that “ there is not enough robust evidence to recommend ivermectin’s use for COVID-19.”
He said there have been a number of well-designed studies that have shown no benefit of ivermectin for COVID-19 treatment. He noted that one of the largest studies, The Together Trial, was stopped due to no benefit being shown.
“However, there are ongoing studies regarding ivermectin that will be reviewed once they are released and reviewed again once they are peer reviewed after release,” he said in August.
What sets this study apart?
The study Lakeland Regional is now a part of is called Activ6, “The Randomized Trial to Evaluate Efficacy of Repurposed Medications.”
The National Institute of Health gave an initial investment of $155 million to get it started, according to a June news release from the agency.
What sets this study apart from others that have been done regarding ivermectin and COVID?
This study is different in many ways, according to Dr. Chris Lindsell, the data coordinating principal for the study who also serves as Director of the Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program.
One difference: it brings the study to the participants.
“Instead of the patient coming to the doctors office to get enrolled, get their medications, and to have measurements made, this study can be done remotely," Lindsell said in an email. "Everything can be done on the computer or over the phone.”
Because the platform is studying medicines with a known safety profile, medicines can be sent directly to someone’s home once it's been confirmed they are eligible to be in the study, he said.
"The study is designed to remove the barriers to getting into research, and reduce the bias on who is offered access to research," he said. Other studies have used different approaches, generally with a smaller number of people.”
He added, “This study is designed as a rigorous, well controlled outpatient trial that will enroll enough people to more completely understand what effects ivermectin has. We expect ACTIV6 will be the most informative data available to help understand these repurposed medicines.”
‘Better late than never’
Polk County Commissioner Combee led a crusade throughout much of the latter part of 2021 to make ivermectin more widely available.
In his effort, he sent a letter to Gov. Ron DeSantis, asking that he make it easier for patients to access the drug.
Combee's letter: Majority of Polk commissioners didn't sign it
Combee said Friday that he never got a response from the governor.
Asked about Lakeland Regional’s new involvement in the national study, he said he doesn’t understand why this hasn’t happened sooner.
“It’s two years later and we are still trying to figure this out,” Combee said, adding “Better late than never.”
A South Carolina native, Dustin covers Polk County government and county-wide issues. He can be reached at email@example.com or on Twitter @LLDustin_Wyatt.
This article originally appeared on The Ledger: Does ivermectin work against COVID? Lakeland hospital joins national study