Essentia joins national COVID-19 medication study
The ACTIV-6 clinical trial will include the study of fluticasone, fluvoxamine and ivermectin to treat mild to moderate COVID infection.
DULUTH — Essentia Health has joined a nationwide COVID-19 treatment study evaluating repurposed medications, the health care system announced Monday morning in a news release.
The ACTIV-6 (Accelerating COVID Therapeutic Interventions and Vaccines) clinical trial will include the study of fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease; fluvoxamine, a selective serotonin re-uptake inhibitor (SSRI), often prescribed for depression; and ivermectin, used to treat parasitic infections.
The medications are already approved by the Food and Drug Administration and considered to be safe and effective for treating other medical diagnoses.
“If enough people diagnosed with COVID-19 participate in this study, we can answer quickly whether these medications will be beneficial in treating mild-to-moderate COVID," Rajesh Prabhu, an infectious disease physician at Essentia, said in the news release. "The aim of the study is to see if these medications make you feel better sooner and prevent hospitalization.”
Participants can choose to participate in one of the drug's studies, and will be randomly assigned either the medication or a placebo to take for the treatment time of three, 10 or 14 days, depending on the medication. Their symptoms and recovery will be tracked through online surveys over a span of 90 days.
To participate in the trial, candidates must be age 30 or older and have tested positive for COVID within the past 10 days. Participants must have at least two of the following COVID symptoms within the last seven days: fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms and/or new loss of taste or smell.
Currently, there are two oral prescription medications that have received emergency use authorization from the FDA. Paxlovid and molnupiravir are only available to individuals considered at higher risk for developing severe COVID infection, but do not require hospitalization. Prabhu said the goal of the ACTIV-6 study is to find treatment for mild to moderate cases of COVID to decrease infection severity and recovery time.
Prabhu said the three medications in the trial were selected because of previous evidence in small COVID treatment studies for their anti-inflammatory properties. Researchers will monitor whether the medications actually do benefit COVID patients.
"There have been small studies that suggest potential benefit, and the purpose of ACTIV-6 as a nationwide study is to enroll 15,000 people," Prabhu said. "The more people you study, the more certainty you have if the medication works or not."
The study, funded by the National Institutes of Health, is led by researchers from Duke Clinical Research Institute and Vanderbilt University Medical Center. It is part of the ACTIV, led by the National Center for Advancing Translational Sciences.
The medications are shipped at no cost to participants. The double-blind study does not require any site visits, therefore, anyone in the United States can participate through web- and phone-based enrollment. Essentia is one of many centers across the country helping facilitate the trials. Participants can receive $100 for completing the study.