FARGO — Essentia Health is taking part in a national study of three approved prescription drugs to test their effectiveness in treating mild or moderate cases of COVID-19.
The study is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines effort led by the National Center for Advancing Translational Sciences.
“This is only for mild and moderate COVID,” said Dr. Rajesh Prabhu, an infectious disease specialist at Essentia. “The purpose is to see if it makes you feel better sooner and to avoid hospitalization.”
The three drugs, all approved by the Food and Drug Administration, are:
- Fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease.
- Fluvoxamine, a selective serotonin reuptake inhibitor, often prescribed for depression.
- Ivermectin, used to treat parasitic infections.
Patients who wish to participate must be at least 30 years of age, 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. Symptoms include fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms or a new loss of taste or smell.
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The use of ivermectin to treat COVID-19 has been controversial in the United States, where there has been little reliable information about its effectiveness.
“There have been small studies that suggest some benefit,” Prabhu said. This will be a large, nationwide study with thousands of participants that will be able to determine the effectiveness of these drugs.
“Everything else has been a mom and pop, kind of a small study,” he said.
Also, in the case of ivermectin, patients were given varying doses and sometimes used veterinary medications, Prabhu said.
Participants will enroll in one of three arms of the study, meaning they will be given only one of the drugs or a placebo through a randomized selection.
Research coordinators will review the results to determine whether the drugs are effective. Based on those results, study leaders will decide whether to continue or halt the study of the drugs.
Participation involves taking the medication and keeping track of symptoms for 90 days through online surveys. Medications will be sent at no cost to participants. No site visits are required, so participants don’t have to live near a research center.
“It’s really an important study,” Prabhu said. The more people who participate likely will mean the earlier results will become available.
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All of the medications in the study are affordable. “These medications are dirt cheap,” Prabhu said. “They have a known safety profile.”
Antiviral medications for COVID-19 are effective but in very limited supply, and doctors have very limited options for treating patients outside the hospital, he said.
The study expects to enroll 15,000 participants from across the United States through its website, activ6study.org, and call center at 833-385-1880.
Potential participants also can call Essentia Health at 866-839-4128 or toll free at 833-383-1880. More information can be found by visiting Essentia online at https://www.essentiahealth.org/ .