TAMPA, Fla. — Tampa General Hospital and USF Health are part of a nationwide study that is looking at older medications to treat COVID-19.
"So ACTIV-6 is for those re-purposed drugs that have at least enough evidence behind them that says there might be a signal here that can help somebody, but more importantly, everything that has been done with them so far, there's really not a signal for harm. And so to make it into the ACTIV-6 group of drugs that might be used, re-purposed, you have to at least meet that level of safety and possible efficacy against NIH study. So that means the bar is very high. The bar is very high for making sure we're doing the study," explained Dr. Jason Wilson.
The study will look at drugs (ivermectin, fluticasone furoate, and fluvoxamine) to see their impact on the omicron variant of COVID-19. The drugs will be taken in an outpatient setting, which means you won't have to leave your house. Right now, there are no FDA-approved drugs to treat mild to moderate symptoms of COVID-19, which this study hopes to look at.
"We're looking just like with vaccines, to see if we can keep people out of the hospital, or keep people from dying from COVID. And that's really about the ACTIV-6 studies looking at prevention of hospitalizations by using repurposed drugs," explains Dr. Wilson
Here are the qualifications you have to meet once you test positive for COVID-19 to participate in the study:
- At least 30 years old and not pregnant
- Tested positive within 10 days
- Have at least two symptoms for seven days or less
- Fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, loss of taste or smell
Once you enter the study, drugs will be sent to your house the next day. You will take them for a few days and the medical team will follow up for a month at different intervals of time. The communication will be via phone calls/mail. The drugs are free and you will be compensated $100.
"So the way this trial is designed, is that we're going to capture thousands of people throughout the country. And we're going to do it fairly quickly because there's so many different trial sites. And it's important to note too, that with ACTIV-6 some sites came online earlier, and some are just ramping up, like us. So the ones who came on earlier had some good tests around the delta variant. And as we come along, we're getting a good test on omicron. The data we're going to get it's going to be really powerful for looking at that. But with four arms, meaning placebo, fluvoxamine, ivermectin, fluticasone. We got to have a lot of people in there to get good samples. So we're hoping to enroll well into the hundreds in this area, and in the 1000s, in the state of Florida," explained Dr. Wilson.
Click here for more information on the ACTIV-6 study and to find out how to enroll.
ACTIV-6 Ivermectin One Pager
ACTIV-6 Fluticasonefuroate One Pager
ACTIV-6 Fluvoxamine One Pager