By Liam Verster

COVID-19 Drug Trial

Hydroxychloroquine will be studied in Alberta as a possible COVID-19 treatment

Apr 13, 2020 | 5:01 PM

Researchers at the University of Calgary and University of Alberta are leading a province-wide study of the effectiveness of hydroxychloroquine (HCQ) as a treatment option for COVID-19.

With support from Alberta Health Services Strategic Clinical Networks and the Government of Alberta, the Alberta HOPE COVID-19 Trial will recruit Albertans who have tested positive for the coronavirus, starting Wednesday, April 15, and treat them with the drug.

Dr. Michael Hill, a Professor of Neurology in the Department of Clinical Neuroscience at the Foothills Hospital at the University of Calgary, and co-lead of the research team, says along with accepting applicants online through Be The Cure or the HOPE COVID-19 Trial, the team will be collaborating with Alberta Health Services. When patients are contacted to be told whether they have tested positive or not, they will be asked by AHS staff if they would like to be involved in the study.

The treatment will be a five-day randomized, double-blind, placebo-controlled trial, to determine whether HCQ can prevent hospitalization for those at high risk of developing a severe illness. The drugs and placebos will be randomized in a 2:1 ratio, with two thirds of the participants receiving hydroxychloroquine. After the treatment, the research team will reach out to the patients on the seventh day, and again on the 30th day, to determine how they reacted to the drugs and whether the treatment was successful.

The drugs and placebos used for the trial are being donated by Apotex, and two courier companies will be used to transport the drugs within one or two days to those who participate in the trial.

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HCQ is known mostly as an antimalarial drug, but is also used to treat inflammatory arthritis and systemic lupus erythematosus.

Dr. Hill says there has been a lot of coverage of this drug in the media leading up to this, with U.S. President Donald Trump advising it’s use. He says though Trump’s claims aren’t presented without any scientific proof, there is a suspicion that it would work as an anti-viral agent.

“Based on some lab data and pre-clinical data, which suggests that hydroxycholoquine is useful as an anti-viral agent, it actually does seem to slow the replication of the virus, and in fact, interestingly, it was used in the original SARS epidemic in 2003, but it wasn’t properly studied. So we don’t really know if it works well against this class of viruses, and there’s an opportunity to [study it’s effectiveness].”

Dr. Hill says the goal of the drug trial is to reduce the chance of severe disease.

“It’s not likely going to cure this problem, but if it reduces the number of people that need to come into hospital for viral pneumonia, or get into ICU, or die from this condition, then that’s a big win for everybody.”

Hill says the treatment is expected to work better if done early, which is why they require the participants to have been diagnosed with a positive case within 96 hours (4 days) of beginning treatment, and 12 days of showing symptoms.

He says, generally speaking, there are very few treatments for viruses available in the world.

“The two viruses that are perhaps most well studied are the HIV virus, and there are lots of drugs that are effective against HIV, and the other one is chicken pox. We have drugs that are good for that family of viruses, the varicella-zoster virus that affects chicken pox. And perhaps, I guess, one other one is the Hepatitis C virus, we have drugs that work there. But other viruses, like the common cold or influenza for example, or in this case, with the coronavirus, we just don’t have any drugs for that.”

Hill adds that administering drugs is not without risk, and it’s important to study the data.

“You can’t just go out and give medicine and things willy-nilly without knowing if they actually work, because you almost always do more harm than good when that’s done. It’s important to note that hydroxychloroquine is not a totally benign drug. Sure, if it was as benign as a banana or something, then we could just give everybody bananas, but that’s not the case here.

“It does have side effects, cardiac side effects, and others. Even though it’s a well known medicine and has been used for many years to treat immune conditions like lupus and rheumatoid arthritis with good effect, we don’t know the full extent of the safety in this situation, when you have a significant viral pneumonia affecting patients.

“So it’s just really important for us to bring data to bear, and that will hopefully help us to understand what’s going on and how to proceed.”

The study is intended to serve people all over the province, and not just the main cities.

Hill adds that the drug is being studied in other places as well, which will offer more comparable data on the effectiveness of the drug in reducing hospitalizations and severe diseases.

He says studying the virus and possible cures or treatments now is critical, because even if the spread reduces in the coming weeks, it’s possible that it could reemerge in the fall or winter.

Hill adds that, even if hydroxychloroquine is found to be ineffective, it’s still very important to do these trials. He says it’s critical to determine it’s use fullness , so they don’t end up administering medicine to people that doesn’t work, and also because it sets the groundwork for future coronavirus drug and vaccine trials.

Participants in this study will be screened to ensure they are over the age of 18, aren’t taking other medicines, and are still within that four day window of time for treatment. Hill says most people, but not everybody, will qualify for this trial if they wish to be involved.

The study is supported by Calgary Health Trust, Alberta Innovates, the Government of Alberta and the University of Calgary/Alberta Health Services Clinical Research Fund.