'We've stepped up': Manitoba researchers begin clinical trial with drug they hope can help in COVID-19 fight

University of Manitoba researchers are testing a potential treatment they hope will help fight COVID-19 — and they think they may have some results from their trial in as little as a month.

Dr. Ryan Zarychanski, an associate professor of internal medicine, said preliminary studies have suggested hydroxychloroquine — a drug approved by Health Canada to prevent and treat malaria since the 1950s — can be repurposed to reduce the severity of COVID-19.

Those preliminary studies point to the possibility hydroxychloroquine may lessen the effects of the illness, such as cough, fever, difficulty breathing and pneumonia in the lungs, and slow its spread.

"There's a lot of scared people. There's a lot of emotion around COVID-19," Zarychanski said, adding scientists are not yet certain of hydroxychloroquine's benefits.

The drug will be studied in a trial with participants who have tested positive for COVID-19, or who live with someone else who has. The trial will also be open to health-care workers who were exposed to patients who have tested positive, the U of M said in a Wednesday press release.

"This is the first of six trials that will offer potentially effective therapies to Manitobans at all stages or severity of the COVID-19 disease instead of shuttering up," Zarychanski said.

For COVID-19-positive people, the hope is that the drug may limit symptoms and shorten the amount of time the illness persists, he said.

The trial, which began recruiting participants on Wednesday, has two goals, according to the study's website:

• Determine whether hydroxychloroquine can prevent development of COVID-19 after exposure to the novel coronavirus that causes the illness.
• Test whether early hydroxychloroquine therapy with people showing COVID-19 symptoms can prevent the illness from progressing, or symptoms from worsening.

"The idea is to reduce the severity of symptoms," said Zarychanski, a critical care doctor, "and also reduce the transmissibility of the virus and reduce community spread, which can help keep our population more healthy and reduce the burden that we're expecting on the healthcare system."

So far, care for people hospitalized with COVID-19 has been dependent on using ventilators until they get better.

"The best way for us to know if a therapy works is to study it, but study it quickly in people who might benefit,"  Zarychanski said. 

People have been cautioned against taking any medications outside supervised studies, though, after U.S. President Donald Trump told reporters last week hydroxychloroquine had shown "very, very encouraging early results" in fighting COVID-19.

Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, quickly noted that officials are trying to strike a balance between making the potential therapy available to physicians and ensuring it is safe and effective through clinical trials.

"I think what happened south of us is that perhaps a very senior leader within their country made public claims that the drug was effective, when in all honesty we're not certain if it's of benefit to patients," Zarychanski said, adding that's exactly what his clinical study is setting out to determine.

"The only way though we can understand whether it's beneficial is within the context of very carefully conducted and monitored clinical trials."

He doesn't believe there would be significant short-term side effects as a result of taking the drug as part of the clinical trial.

"It can interact with other drugs and it may have some short-term cardiac issues, and so we make sure we understand what other drugs people are on before they sign up for the trial," he said.

In the long run, it is known to cause cardiac and eye toxicity, although the short five-day trial should be "very safe," he said.

'Moved mountains' to start study quickly

"This is a very exciting trial because it's not just about treating individuals but it's about trying to sort of flatten that epidemiologic curve," Zarychanski said.

"We're not only offering the therapy to the positive people but to the family members of those positive people who then could pass it on to other people."

To provide a control group, half of participants will be given the actual drug, and the other half will receive a placebo.

Zarychanski said the study — being conducted through the University of Manitoba, in conjunction with researchers at the University of Minnesota, University of Alberta, and the Research Institute of the McGill University Health Centre — is remarkable for how quickly it's progressed.

"The University Manitoba has moved mountains over the course of one week," he said. "In the setting of a pandemic and the need to bring drug trials urgently to the population, we've stepped up."

It usually takes six months up to a year to get clinical trails going. In this case, Zarychanski said it took only five days to get the green light from Health Canada, ethics approval, staff in place and a website running.

Scientists are relying on the media and word of mouth to recruit participants.

Anyone who believes they may be eligible can fill out screening questions and provide consent through the study's website.

Because COVID-19 is highly contagious, participants won't visit the researchers in a lab setting. 

Instead, the drug or placebo will be shipped to the participant the day after they are enrolled in the trial, the U of Manitoba said. The study is open to those who researchers can deliver the drug to within 24 hours.