Franciscan Health Michigan City has joined a nationwide study to evaluate repurposed medications in the search for effective, safe treatments for mild-to-moderate COVID-19. Repurposed medications are already approved by the U.S. Food and Drug Administration with known safety records, which are being tested for a new purpose.
Infectious disease physician Dafer Al-Haddadin, MD, serves as principal investigator for the research site at Franciscan Health Michigan City. “We are trying to be part of the future solution for COVID-19 and are excited to provide our community the benefit of such clinical trials. We ask everyone to join and help spread the word to anyone who may qualify for the study,” he said.
ACTIV-6, “The Randomized Trial to Evaluate Efficacy of Repurposed Medications,” is a double-blind study now testing these repurposed medications:
- Fluticasone, an inhaled steroid commonly prescribed for asthma and chronic obstructive pulmonary disease.
- Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), often prescribed for depression.
- Ivermectin, used to treat parasitic infections.
To be eligible, participants must be age 30 or older, 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, and/or new loss of sense of taste or smell.
The study is part of the National Institutes of Health-funded Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) led by the National Center for Advancing Translational Sciences. The Duke Clinical Research Institute serves as the study’s clinical coordinating center, partnering with Vanderbilt University Medical Center as the study’s data coordinating center. The study is expected to enroll nearly 15,000 participants from across the United States.
One of the first participants in the study at Franciscan Health Michigan City was Steve Cammett. The 69-year-old had returned from a cruise and began feeling like he had a cold. A friend who had lost her parents to COVID convinced him to get tested, and his results came back positive.
“I’m glad I was vaccinated, that’s made a big difference,” Cammett said. He also said he was fortunate to already have a relationship with Dr. Al-Haddadin as his infectious disease doctor. Dr. Al-Haddadin recommended a monoclonal antibody infusion, since Cammett was early in his diagnosis, and then asked if he would be interested in also participating in the study. “I’m a former IT guy, so I research everything. I went out and did fairly in-depth research on what the study was and who was doing it,” he said.
“Because of my age and comorbidities, I knew I was in a high-risk group,” said Cammett, who called his decision to participate “almost a no-brainer.”
Those interested in participating in the study can contact the Franciscan Health Michigan City Research Center at (219) 809-9461 or go online at the national website, activ6study.org or contact the national call center at (833) 385-1880.
Patients will fill out a screening form to be contacted by a study team member and determine eligibility. Patients who qualify will be provided an informed consent, and will be randomly chosen to take the drugs or a placebo. The study drug will be shipped to the participant, and patients will be monitored through follow-up visits. Patients will be able to call at any time with concerns or questions.
Speeding enrollment in the ACTIV-6 study is of critical importance as the pandemic evolves and highly transmissible variants appear throughout the nation and around the world. The study will yield valuable data on whether repurposed medications can help address the unmet public health need for people experiencing mild-to-moderate COVID-19 symptoms.