The study, conducted by the Duke Clinical Research Institute, is a nationwide double-blind study expected to enroll nearly 15,000 participants from across the United States and hopes to discover new COVID-19 treatments using already existing drugs.
The nationwide effort is called ACTIV-6 and is testing three drugs:
- Fluticasone, also known as Flonase, a corticosteroid often used for asthma or chronic obstructive pulmonary disease that is delivered via inhaler.
- Fluvoxamine, an antidepressant in pill form.
- Ivermectin, which is used to treat parasitic infections in both humans and livestock.
The Food and Drug Administration urges against taking Ivermectin to treat COVID-19, but some COVID patients are advocating for the option to take it in hospitals. The trial will allow researchers to test the drug in a safe and controlled environment.
“We have treatments for people with severe COVID-19 who are at high risk for hospitalization or death, but they are complex to administer,” said Adrian Hernandez, MD, the study’s administrative principal investigator in a release. “Currently, there are no approved prescription medications that can be easily given at home to treat mild-to-moderate symptoms of the virus early in its course to prevent worsening of COVID-19.”
Researchers at the Medical University of South Carolina (MUSC) are part of the study.
“As I was telling people, if you don’t believe in Ivermectin — or if you do believe in it — this is your chance to contribute to us understanding whether it works or not,” Dr. Leslie Lenert, director of the Biomedical Informatics Center at MUSC, said.
People interested are required to be over 30 years old, have a positive COVID-19 test in the past 10 days and have experienced at least two COVID-19 symptoms within the past seven days. Symptoms include fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms and/or new loss of sense of taste or smell.
If you meet those requirements, you can sign up and be randomly assigned to one of the three treatments or a placebo.
Once you’re accepted into the trial, the central pharmacies mail the study drug and a pulse oximeter to your home.
Then, participants will take the study medication as directed, fill out daily surveys online and respond to phone call questionnaires on days 14 and 28.
After 90 days, the participants each receive a $100 Amazon gift card as a thank-you gesture for their time and participation in the clinical trial.
Anyone interested in participating in the ACTIV-6 study can call (843)-792-4675 or visit the study website.