Researchers with the OneFlorida+ Clinical Research Network have begun recruiting patients to a national study to learn if several existing prescription and over-the-counter medications can help those with COVID-19 safely manage their symptoms at home and avoid hospitalization.
The study is one of several research projects that are part of the Accelerating COVID‑19 Therapeutic Interventions and Vaccines, or ACTIV, public-private partnership funded by the National Institutes of Health. The ACTIV-6 study will explore several drugs already approved by the U.S. Food and Drug Administration for other conditions — an approach called drug repurposing — to test the drugs’ safety and effectiveness in treating COVID-19.
Currently, no therapies have been approved by the FDA specifically to treat COVID-19 symptoms such as fatigue, shortness of breath, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal congestion or loss of sense of taste or smell.
“In the ACTIV-6 study, we’ll be testing a select group of existing drugs that are FDA approved for other conditions, that already have an established safety record and that have shown early indications of effectiveness against the symptoms of COVID-19 in small, preliminary studies,” said Elizabeth A. Shenkman, Ph.D., 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. “Our main goal is to identify which of those drugs 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, M.D., an assistant professor in the UF College of Medicine’s division of internal medicine, serves as the UF Health physician site principal investigator.
Enrollment in Florida will be coordinated through the OneFlorida+ Clinical Research Network, which includes 14 health systems and clinical partners in all 67 counties, together with metro areas in Atlanta, Georgia and Birmingham, Alabama. OneFlorida+ is one of eight regional clinical research networks nationwide participating in PCORnet, the national patient-centered clinical research network. PCORnet enables scientists to quickly access enrolling sites and streamline study start
–up timelines to help accelerate research. OneFlorida+ partners participating in the ACTIV-6 study include UF Health, UF Health Jacksonville, the UF Health Precision Health Research Center – The Villages, Tallahassee Memorial HealthCare, the University of South Florida in Tampa, Lakeland Regional Healthcare, the University of Miami and Jackson Memorial Hospital in Miami, and Emory University in Atlanta.
Shenkman said the study team initially will test three drugs that have shown early signs of efficacy against COVID-19 in preliminary studies: fluticasone, an inhaled steroid commonly used to treat asthma and chronic obstructive pulmonary disease; fluvoxamine, a drug prescribed to treat depression; and ivermectin, an antiparasitic drug in the form of a pill prescribed to treat people with infections caused by some parasitic worms. Ivermectin made headlines after some people began using veterinary forms of the drug intended for use in livestock to prevent or treat COVID-19 symptoms even though there’s no strong clinical evidence that ivermectin works. The ivermectin being tested in the ACTIV-6 study is an FDA-approved form of the drug for use in humans.
“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.”
Additional drugs will be added to the ACTIV-6 study as they are identified over time.
With funding provided by the American Rescue Plan Act, the NIH’s National Center for Advancing Translational Sciences, or NCATS, is overseeing the study, which is expected to enroll up to 15,000 participants through multiple recruitment sites nationwide.
Study participants must be at least 30 years old, have tested positive for infection with SARS-CoV-2, the virus that causes COVID-19, and have had two or more mild to moderate symptoms of COVID-19 for no more than seven days.
“One study goal is to enroll people in minority, rural and other communities that have been significantly affected by COVID-19,” Shenkman said.
In a break with tradition, the “low-touch” ACTIV-6 study allows people to participate from home. Participants can enroll and fill out symptom diaries and questionnaires online or over the phone. Study drugs will be mailed to participants’ homes and study visits with the research team will be conducted online whenever possible.
“This is especially important when people with active COVID-19 infections are expected to isolate and may not feel well enough to travel to a clinic for a study visit,” Shenkman said. The remote study design also minimizes the study team’s risk of exposure to COVID-19.
Participants will be assigned randomly to receive either a placebo or one of the treatments. They will be asked to record changes in their symptoms over a 14-day period. Researchers will also track the number of participant hospitalizations and deaths over a 28-day period. Lastly, 90 days after treatment begins, participants will be asked if they are experiencing any long-term COVID-19-related symptoms.
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 (https://activ6study.org) or call 833-385-1880.
Consumer alert about using ivermectin to self-treat or prevent COVID-19
You may have heard news reports about people using the antiparasitic drug ivermectin to prevent or treat COVID-19. Is it safe? Is it effective? Should you use it?
Ivermectin was introduced in 1971 as an animal de-wormer. The drug was approved for human use in 1986 to kill parasites that cause river blindness and other illnesses. Ivermectin comes in many forms, including prescription tablets for ingestion by people infected with certain intestinal parasites; topical creams, shampoos and lotions that are applied to the skin to treat people with head lice and skin conditions like rosacea; and veterinary products intended for use in animals only.
Unless you are enrolled in one of the ongoing clinical trials to evaluate ivermectin as a treatment for COVID-19, the FDA, Centers for Disease Control and Prevention, National Institutes of Health and World Health Organization recommend against using ivermectin to treat or prevent COVID-19 until these large clinical trials can definitively show whether the drug is effective against COVID-19.
ACTIV-6 is a randomized, controlled clinical trial, meaning that participants will be assigned randomly to receive either a placebo or one of the treatments, which will be sent to them by mail. During the study, no one on the study team nor any of the people enrolled will know which participants received one of the study drugs and which ones received the placebo. If necessary, this information can be obtained from the study team. Throughout the study, a physician-led research team will oversee and monitor all participants.
As with all drugs, ivermectin has side effects, but when used as prescribed for the approved indications, this drug is safe, effective and well tolerated. The World Health Organization lists ivermectin as one of its essential medicines used to treat people with parasitic diseases.
The dosage of ivermectin being evaluated as a COVID-19 treatment in the ACTIV-6 clinical trial has already been safety-tested and approved for use in humans. However, taking large doses of ivermectin, using ivermectin products made for animals, or swallowing ivermectin products meant for use on the skin is dangerous and may be harmful.
Read the Sept. 3, 2021 FDA Consumer Advisory on ivermectin.