Ups and downs of Hydroxychloroquine has slowed enrollment of U of M trials

Hydroxychloroquine is a drug few people could pronounce, let alone understand, more than two months ago.

Now it’s in the headlines nearly every day as researchers, including those at the University of Minnesota, study to see if it can treat or prevent COVID-19.

The experience has been somewhat of a rollercoaster over the last three months for Dr. Radha Rajasingham and her team at the university.

“I try not to get too caught up with the drama,” she said. “This was the best thing since sliced bread in early April and then it was ‘Don't get this, I don't want to be in a room with this drug.'”

Hydroxychloroquine is a decades-old anti-malaria drug that researchers around the country have been focused on to see if it can fend over the novel coronavirus. 

It’s also the drug that President Donald Trump has praised since March, at one point tweeting that it is possibly “One of the biggest game-changers in the history of medicine.”

But that excitement slowly faded when other studies found the drug was not effective and could even lead to other serious health problems.

Rajasingham said the negative headlines had a significant impact on the number of willing participants at the university.

“People don’t want to enroll in our studies when they see that,” she said. “They’re like 'Why would I enroll if it doesn’t work?'”

Rajasingham stands behind her group’s work and the safety of the drug that they give volunteers. She said the recent studies have been small and failed to compare the results against a so-called control group – the random group that receives placebos instead of the real drug.
 
But perhaps the biggest hit came at the end of April, when the Food and Drug Administration (FDA) came out with a warning that cautioned against the use of the drug outside of a hospital or clinical trial.

“With the FDA warning, everyone felt that this was a really dangerous drug. And so we've kind of had to look through our safety events,” she said. “There were inevitably some people who wanted out. They didn't want to take the drug anymore.”

Rajasingham’s study, which is specifically looking at whether the drug can prevent an infection of COVID-19, currently has about 1,500 volunteers. The team may end the study early due to slowing enrollment.

Meanwhile, results from the other two hydroxychloroquine studies at the University of Minnesota could be out as soon as this week.