UF Health joins national study to test COVID-19 treatments

GAINESVILLE, Fla. – Researchers astatine University of Florida Health and the OneFlorida+ Clinical Research Network person begun recruiting patients to a nationalist survey to larn if respective existing medicine and over-the-counter medications tin assistance those with COVID-19 safely negociate their symptoms astatine location and debar hospitalization.

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The survey is 1 of respective probe projects that are portion of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines, oregon ACTIV, public-private concern funded by the National Institutes of Health. The ACTIV-6 survey volition research respective drugs already approved by the U.S. Food and Drug Administration for different conditions — an attack called cause repurposing — to trial the drugs’ information and effectiveness successful treating COVID-19.

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Currently, nary therapies person been approved by the FDA specifically to dainty COVID-19 symptoms specified arsenic fatigue, shortness of breath, fever, cough, nausea, vomiting, diarrhea, assemblage aches, chills, headache, sore throat, nasal congestion oregon nonaccomplishment of consciousness of sensation oregon smell.

“In the ACTIV-6 study, we’ll beryllium investigating a prime radical of existing drugs that are FDA approved for different conditions, that already person an established information grounds and that person shown aboriginal indications of effectiveness against the symptoms of COVID-19 successful small, preliminary studies,” said Elizabeth A. Shenkman, seat of the department of wellness outcomes and biomedical informatics successful the College of Medicine astatine UF and co-principal researcher of the OneFlorida+ Clinical Research Network. “Our main extremity is to place which of those drugs tin assistance radical consciousness amended faster and support them retired of the hospital.”

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Shenkman serves arsenic the UF Health tract main researcher for ACTIV-6. Dr. Christina Li, an adjunct prof successful the UF College of Medicine’s part of interior medicine, serves arsenic the UF Health doc tract main investigator.

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Shenkman said the survey squad initially volition trial 3 drugs that person shown aboriginal signs of efficacy against COVID-19 successful preliminary studies: fluticasone, an inhaled steroid commonly utilized to dainty asthma and chronic obstructive pulmonary disease; fluvoxamine, a cause prescribed to dainty depression; and ivermectin, an antiparasitic cause successful the signifier of a pill prescribed to dainty radical with infections caused by immoderate parasitic worms. Ivermectin made headlines aft immoderate radical began utilizing veterinary forms of the cause intended for usage successful livestock to forestall oregon dainty COVID-19 symptoms adjacent though there’s nary beardown objective grounds that ivermectin works. The ivermectin being tested successful the ACTIV-6 survey is an FDA-approved signifier of the cause for usage successful humans.

“The lone mode to corroborate that these drugs are harmless and effectual for treating the symptoms of COVID-19 is with a large, controlled objective probe study,” Shenkman said. “We anticipation ACTIV-6 volition connection scientifically rigorous, definitive results.”

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Additional drugs volition beryllium added to the ACTIV-6 survey arsenic they are identified implicit time.

With backing provided by the American Rescue Plan Act, the NIH’s National Center for Advancing Translational Sciences, oregon NCATS, is overseeing the study, which is expected to enroll up to 15,000 participants done aggregate recruitment sites nationwide.

Enrollment successful Florida volition beryllium coordinated done the OneFlorida+ Clinical Research Network, which includes 14 wellness systems and objective partners successful each 67 counties, unneurotic with metro areas successful Atlanta, Georgia and Birmingham, Alabama. OneFlorida+ is 1 of 8 determination objective probe networks nationwide participating successful PCORnet, the nationalist patient-centered objective probe network. PCORnet enables scientists to rapidly entree enrolling sites and streamline survey start-up timelines to assistance accelerate research. OneFlorida+ partners participating successful the ACTIV-6 survey see UF Health, UF Health Jacksonville, the UF Health Precision Health Research Center – The Villages, Tallahassee Memorial HealthCare, the University of South Florida successful Tampa, Lakeland Regional Healthcare, the University of Miami and Jackson Memorial Hospital successful Miami, and Emory University successful Atlanta.

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The UF Health squad hopes to enroll up to 200 participants. Study participants indispensable beryllium astatine slightest 30 years old, person tested affirmative for corruption with SARS-CoV-2, the microorganism that causes COVID-19, and person had 2 oregon much mild to mean symptoms of COVID-19 for nary much than 7 days.

“One survey extremity is to enroll radical successful minority, agrarian and different communities that person been importantly affected by COVID-19,” Shenkman said.

In a interruption with tradition, the “low-touch” ACTIV-6 survey allows radical to enactment from home. Participants tin enroll and capable retired grounds diaries and questionnaires online oregon implicit the phone. Study drugs volition beryllium mailed to participants’ homes and survey visits with the probe squad volition beryllium conducted online whenever possible.

“This is particularly important erstwhile radical with progressive COVID-19 infections are expected to isolate and whitethorn not consciousness good capable to question to a session for a survey visit,” Shenkman said. The distant survey plan besides minimizes the survey team’s hazard of vulnerability to COVID-19.

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Participants volition beryllium assigned randomly to person either a placebo oregon 1 of the treatments. They volition beryllium asked to grounds changes successful their symptoms implicit a 14-day period. Researchers volition besides way the fig of subordinate hospitalizations and deaths implicit a 28-day period. Lastly, 90 days aft attraction begins, participants volition beryllium asked if they are experiencing immoderate semipermanent COVID-19-related symptoms.

The Duke Clinical Research Institute successful Durham, North Carolina, serves arsenic the study’s objective coordinating center, partnering with Vanderbilt University Medical Center successful Nashville, Tennessee, arsenic the study’s information coordinating center.

For much information, sojourn the ACTIV-6 Study website (https://activ6study.org) oregon telephone 833-385-1880.

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Consumer alert astir utilizing ivermectin to self-treat oregon forestall COVID-19

You whitethorn person heard quality reports astir radical utilizing the antiparasitic cause ivermectin to forestall oregon dainty COVID-19. Is it safe? Is it effective? Should you usage it?

Ivermectin was introduced successful 1971 arsenic an carnal de-wormer. The cause was approved for quality usage successful 1986 to termination parasites that origin stream blindness and different illnesses. Ivermectin comes successful galore forms, including medicine tablets for ingestion by radical infected with definite intestinal parasites; topical creams, shampoos and lotions that are applied to the tegument to dainty radical with caput lice and tegument conditions similar rosacea; and veterinary products intended for usage successful animals only.

Unless you are enrolled successful 1 of the ongoing objective trials to measure ivermectin arsenic a attraction for COVID-19, the FDA, Centers for Disease Control and Prevention, National Institutes of Health and World Health Organization urge against utilizing ivermectin to dainty oregon forestall COVID-19 until these ample objective trials tin definitively amusement whether the cause is effectual against COVID-19.

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ACTIV-6 is simply a randomized, controlled objective trial, meaning that participants volition beryllium assigned randomly to person either a placebo oregon 1 of the treatments, which volition beryllium sent to them by mail. During the study, nary 1 connected the survey squad nor immoderate of the radical enrolled volition cognize which participants received 1 of the survey drugs and which ones received the placebo. If necessary, this accusation tin beryllium obtained from the survey team. Throughout the study, a physician-led probe squad volition oversee and show each participants.

As with each drugs, ivermectin has broadside effects, but erstwhile utilized arsenic prescribed for the approved indications, this cause is safe, effectual and good tolerated. The World Health Organization lists ivermectin arsenic 1 of its indispensable medicines utilized to dainty radical with parasitic diseases.

The dosage of ivermectin being evaluated arsenic a COVID-19 attraction successful the ACTIV-6 objective proceedings has already been safety-tested and approved for usage successful humans. However, taking ample doses of ivermectin, utilizing ivermectin products made for animals, oregon swallowing ivermectin products meant for usage connected the tegument is unsafe and whitethorn beryllium harmful.

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Read the Sept. 3, 2021 FDA Consumer Advisory connected ivermectin.

Reprinted with support from University of Florida Health Communications