The first COVID-19 treatment trial in the world to include pregnant women was just launched. Now, researchers need patients to enroll.
They're studying a long-approved diabetes medicine which they believe will be effective in keeping people out of the hospital and/or dying from COVID-19.
“We need 570 people,” said Dr. Carolyn Bramante, lead investigator of the study and assistant professor of internal medicine and pediatrics at the University of Minnesota Medical School.
570 people need to enroll within 3 days of receiving a positive COVID-19 test. It's a specific number and statisticians have carefully mapped out the percentages as to why that number works. Participants will either get a placebo or a diabetes drug called "metformin."
“Those analyses did find that people who had been on metformin before they got COVID-19 were less likely to be hospitalized or die than similar people who were not on metformin,” said Bramante.
If you're wondering how a diabetes drug relates to a respiratory virus like COVID-19, you're not alone.
“It’s very confusing, too, we have had people ask, 'well, if metformin might reduce severity, why is diabetes such a big risk for poor outcomes from COVID.' Which is a great question. Diabetes is a state of chronic inflammation, type 2 diabetes and high blood sugar, both of those things seem to make the severity of COVID-19 worse.”
Bramante says metformin has also been effective in treating Zika and Hepatitis C. It's even been used to enhance fertility. The drug has been FDA approved for decades. Kids have taken it, as have pregnant women.
“It's clearly easier to study something that has already been used in pregnant people because you have data to fall back on in discussing in general the risks of using that medication in pregnancy,” said Dr. Sarah Cross. She's a high-risk obstetrician and assistant professor at the University of Minnesota Medical School.
Pregnant women are generally excluded from drug trials, COVID-19 or otherwise. Dr. Cross says that can be risky.
“Because then you don’t know how something works in pregnancy. And, if you don’t have any data, then every time you talk to somebody you say, 'well, you have this medical condition, you have high blood pressure, and I'd like to give you this medication, but it's never been studied in pregnancy, so I don’t really know.'”
Researchers hope people, including those who are pregnant, will enroll in this trial. Even with the vaccine coming out, Dr. Bramante says metformin is an available and inexpensive treatment that could improve survivability. But they need the study and those 570 people to prove it. It's a simple sign up and doctors say it's a safe drug.
“This would be people who were recently diagnosed with sars cov2 and they don’t have to have symptoms, but they have to have had a positive test within 3 days,” said Bramante.
If you're interested you can sign up at covidout.com.