By Liam Verster

Possible COVID-19 treatment study in Alberta

Hydroxychloroquine study enters second week with a call for more participation

Apr 27, 2020 | 4:30 AM

The Alberta Hope COVID-19 study is on it’s second week of testing hydroxychloroquine as a possible treatment for the novel coronavirus.

The study, which is jointly run by researchers based out of the University of Alberta and the University of Calgary, and is supported by Alberta Health Services and the Government of Alberta, is testing those who have recently been diagnosed with the novel coronavirus, to determine whether or not this drug is effective at combatting the virus.

Dr. Michael Hill, a professor at the University of Calgary and a co-lead on the Alberta Hope COVID-19 study, says they have already recruited over 70 participants, but do need more participation in order to collect enough data to come up with conclusive results.

“Our goal continues to be to try to get high quality data, to try to understand whether this treatment either works or does not work. Both outcomes are important ones.”

“Obviously if it doesn’t work, that’s actually useful, to tell people not to take [hydroxychloroquine], and that’s something that I think people always forget, that it’s good to have negative studies as well. And if it does work, well then even better, we’ve got a readily available treatment for people who happen to get sick with the virus.”

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The study is based on public participation, with individuals being contacted by AHS, informing them of the positive result, then asking if they would be willing to be a part of the study. Hill says, of those asked, two thirds decline. He says it may seem scary to be a test subject of a drug, but adds that there are requirements to ensure their well being is safe.

“Because we’re being really careful about safety, many people do not qualify for the trial, because they have, for example, are on medicine for which it would be dangerous for them to take additional medicine like hydroxychloroquine. So, we are being cautious about making sure that it’s really safe for people to be involved in this study.”

He says by following these requirements, they do not put anyone at risk of adverse side effects, like the ones recorded in New York last week that led to the FDA advising doctors in the US to not prescribe the drug to patients. Hill adds that, unlike the US, they are not testing the drug on patients already in the hospital, and just on those who are self-quarantined with moderate symptoms.

“I think it’s important to recognize that, as with all medicines, [hydroxychloroquine ] does have some side effects. And we have to be aware, we are aware of that, and make sure we don’t put anybody in danger, while at the same time really trying to understand if we can make people better.”

He adds, for any drug and under any circumstance, treatment should not be done without evidence that the drug will work, or won’t make the situation worse for the patient, which is why this study is so necessary at this time.

“What’s happening is that even in the physician and medical community, there’s anxiety about what to do with there patients. It’s a totally new situation, and when those things happen, people aren’t always rational. And/or you’ve got a very sick patient in front of you and you just want to do something to try to help them, and so you’re grasping for ‘well, what can I do to help this person?’ And sometimes anecdote creeps into treatment decision making, and you can result, unfortunately, in problems.”

“The best way to manage this is to get high quality data from randomized trials to guide treatment decisions, so that we’re giving both medicines and treatments that we know are safe and effective. It’s going to take time to gather, and it’s one of the reasons that we tried to mobilize this trial as quickly as possible, so that we can actually have an impact on what’s going on in our community, and around the world.”

Health Canada has advised Canadians to not take hydroxychloroquine or chloroquine without medical supervision to treat the novel coronavirus. There is concern that the drugs can have serious side effects, including heart rhythm problems, which in some cases can be fatal. However, the health authority is permitting clinical trials of the drug as a possible treatment, as the effects are not fully known at this time. Health Canada says the only way to find out if the benefits of these drugs outweigh their risks is through controlled, clinical trials, and they ask that Canadians do not buy or take these drugs without consulting their doctor first.

The first patients began treatment last Wednesday, and the study is blind, with two thirds receiving the actual drug, and the rest receiving a placebo. Because of this, there won’t be any conclusive evidence for some time still.

“There will be an interim analysis which will be done by a blinded safety kit, on a Data Safety Monitoring Board, but we won’t have anything to announce until we get close to the end.”

At this point, there is no information or data gathered until after patients undergo 30 days of treatment. A follow up with patients will be done to collect data and information, which will be used as evidence in the effectiveness of hydroxychloroquine as a viable treatment for COVID-19.

Hill adds that all the modelling suggests this pandemic will last many months still, and the more research that can be done now, the sooner a cure or treatment can be found, which will lead to loosening restrictions and opening up the province again.

He encourages anyone who has tested positive within the past few days, or who received a call telling them they are carrying the virus, to participate in the study, and help determine the effectiveness of hydroxychloroquine in battling COVID-19.