Researchers worry Trump-related politics could play role in COVID-19 drug trial

A Manitoba researcher worries people in the province could shy away from enrolling in a drug trial because of the politics attached to the medication being studied.

The study is an attempt to find out whether taking the drughydroxychloroquine can help prevent front-line health-care workers from getting the disease.

"Some of the challenges have been that hydroxychloroquine, unfortunately, has been a very politically charged kind of drug in this COVID-19 epidemic," said Dr. Sylvain Lother, an infectious disease and critical care physician at the University of Manitobaand a sub-investigator on the drug trial.

U.S. President Donald Trump told reporters on Monday that he has been taking the malaria drug to protect himself from the novel coronavirus for about a week and a half, despite warnings from his own government that it should only be administered for COVID-19 in a hospital or research setting due to potentially fatal side-effects.

Trump spent weeks pushing the drug as a potential cure or prevention for COVID-19 against the cautionary advice of many of his administration's top medical professionals. The U.S. Food and Drug Administration has cautioned against using the drug outside of a clinical setting because of a potential for harmful side-effects when taken with other medications.

"In early April, many people on social media and in mainstream media were touting hydroxychloroquine to be a game changer and thinking that this drug was going to completely revolutionize the pandemic," Lother said.

"And because of that, people have sort of developed very polarized opinions about hydroxychloroquine."

Cross-border clinical trials suffer amid hype

The trial is part of a collaboration by researchers on both sides of the Canada-U.S.border.

The U of M is heading uppart of the study in conjunction with the University of Minnesota in the United States and the Research Institute of the McGill University Health Centre in Quebec.

Lead investigator Dr. Radha Rajasingham said participants are being prescribed to take hydroxychloroquineor a placebo, then surveyed on aweeklybasis about the side effects, symptoms and their exposures.

"Really what we want to know is do they develop COVID-19while on this drug, and whether this drug can prevent them from developing it," she said.

The assistant professor of medicine at the University of Minnesotasaid her research team will determine ifthe drug is working by comparing the incident rate of COVID-19 among participants of the two camps.

"Because they're randomized, that incident should be exactly the same if there's no effect of the drug, but if the drug is truly preventing it, then fewer people should develop COVID-19 if they're on that medicine," she said.

When the study first began earlier this spring,Rajasinghamsaid there was "a lot of excitement" around it. That was until about two weeks after people started enrolling, around when she said the FDA issued its warningthat prompted a"change in sentiment" across the country.

"Everyone started to worry that this was a dangerous drug, that it caused [heart] arrhythmias and no one should be on it," she said.

"It has a lot to do with what the president is doing," she said.

As an infectious disease doctor based in the U.S. during all the hype, she said she believes the FDA warning was triggered by two previous studies that used "very, very high doses" in "really sick people who were hospitalized," which is a different population than the younger, healthier folks in her study.

It has created a bit of an ethical dilemma given "all of these ups and downs" based on peoples' beliefs, which is split across political linesdespite the science, she said.

"As a result, a lot of people have very strong feelings about what we're doing and why we're doing it, but from our sort of more data-driven perspective, there are no randomized double-blind placebo-controlled trials that have published the results of whether this drug can prevent or treat COVID-19," she said.

"I think it's really interesting that this medication that's been around for so long is being politicized."

Hydroxychloroquine has been used for decades to prevent and treat malaria, and also forsymptoms oflupus and rheumatoid arthritis.

The study is a pre-exposure prophylaxis trial, which means it's looking to see whether use of the drug before exposureto the virus can prevent the disease.

"We view it as a tool in the whole toolbox of things that we use to prevent ourselves from getting infection," said Lother, who works directly with COVID-19 patients.

"We know that,even in the context of wearing appropriate PPE, that health-care workers are disproportionately affected by COVID-19 across the world."

Few Manitoba applicants

The study aims to include at least 3,200 participants on both sides of the border, the lead investigator said.

So far in the U.S., there are just over 1,400 people enrolled. Since launching the trial in Canada last week, there have been just three applicants from Manitoba, Lother said.

"It's been politically charged and that has prevented us from enrolling as quickly as we would have liked to over the last few weeks, so we hope that, you know, people will see past that."

Recruitment for hydroxychloroquine studies has become an issue on both sides of the border, Lother said.

"Initially we had a lot of large amounts of enrolments in these trials, and we've really seen a flattening of the curve in terms of our enrolment just from different opinions that have been coming out."

Despite earlier warnings from the FDA, researchers say the drug is safe if used in a clinical trial because participants are screened and monitored closely. The drug also has been used safely to prevent other infections, like malaria, for years.

In addition to the polarizing political views on the drug, the relatively low number of COVID-19 cases in the province may be a factor, Lother said.

"Some of that initial fear might be dwindling away, and for that reason, people might feel a little less vulnerable than they did initially," he said.

Health-care workers still face a significant risk, and studying the drug could be very helpful in preparing for a second wave of the virus if it occurs, Lother said.

Many people may also be avoiding the clinical trial because of the fear of receiving a placebo, Lother said.

"The bottom line is we don't know if this medication works or not," he said. "There's a chance that it could work, but we need to prove that scientifically with trials."

Chief Provincial Public Health Officer Brent Roussinsaid Thursday that taking the drug only makes sense as part of a clinical trial.

"The only reason for using [hydroxychloroquine] for the treatment or prevention of COVID-19 would be as part of a clinical trial, because there isn't evidence that it's effective," hesaid.