CALGARY -- Alberta researchers have started a large clinical trial of hydroxychloroquine (HCQ) to determine whether administering the drug early in a COVID-19 infection will help people battle the virus.
The researchers, led by a team from the University of Calgary's Cumming School of Medicine, will recruit 1,600 Albertans to determine whether a five-day treatment of HCQ can prevent hospitalization for people at highest risk of developing severe complications from coronavirus.
The website for the trial, hopecovid.ca, hope to demonstrate that HCQ has clinical benefit for both patients and the healthcare system, if provided soon after confirmation of diagnosis.
"A nice way to think about this is, let’s see if we can turn this into a common cold for everybody, so they are sick for a week and they get better and it’s no big deal," says research co-leader Dr. Michael Hill. "Obviously, if we hit a home run and it turns out this treatment is helpful, then that is fantastic. That’s an amazing thing and will influence the outcome of what’s going on. If we get a negative result, that’s useful too because it will stop people taking a drug which could be harmful."
The trial will be open to Albertans who are at home with COVID-19, proven by testing. To be eligible, they must be 18 years old with an underlying medical condition associated with severe illness resulting from COVID-19 infections or be taking medication associated with more frequent or more severe outcomes.
People over 40 will also be eligible, as that is the point at which more severe outcomes begin to increase.
To participate, a patient must be able to begin the trial within 96 hours of receiving their positive COVID-19 result, and within 12 days of the onset of their symptoms.
Staff from Alberta Health Services (AHS) will be contacting people who have received a positive diagnosis for COVID-19 to ask if they are interested in participating. Volunteers will be screened for safety and eligibility, and must agree to allow researchers access to their electronic health record. Once accepted into the study the treatment will be delivered by courier to the patient’s door, anywhere in Alberta.
"We have research teams in both Calgary and Edmonton, and we have processes to even include people who live in remote parts of the province," says research co-leader Dr. Luanne Metz. "The fact that this is a huge number of potential participants is good because then we can get the numbers in quickly and hopefully get an answer very fast."
Not everyone in the drug trial will be given the actual medication. In the 'double-blind' study, two-thirds of the participants will receive HCQ and one-third will be given a placebo. During the study, neither the patient nor the researchers know which patients are actually receiving the drug.
HCQ is originally a drug used to prevent malaria, and is presently used most often to treat immunological disorders like lupus and rheumatoid arthritis. Laboratory studies also suggest that it may be helpful against the COVID-19 virus, however, to date there have only been very small studies suggesting clinical benefit.
Although HCQ is considered a safe and well-known drug it still has potentially serious side effects. As a result some people may not be eligible for the survey, including those who:
- Are currently in, or imminently have a planned admission to hospital
- Any contraindication to hydroxychloroquine
- Have participated in a interventional clinical trial within the last 30 days in or are participating in one now
- Use or have used hydroxychloroquine (Plaquenil) or chloroquine, lumefantrine, mefloquine or quinine within the previous 30 days
- Have an inability to swallow pills or any other reason that compliance with the medical regimen is not likely
- Are pregnant or breastfeeding
- Have a severe underlying disease where treatment is not likely to be beneficial to the patient
Participants must also agree to use adequate contraception for the duration of the study, as HCQ can potentially cause birth defects.
A concurrent study is also underway at the University of Alberta. It is looking at whether HCQ can help prevent infection with COVID-19. That study targets people living in the same home as a person diagnosed with COVID-19, but who have not tested positive for the disease.
This study is international in scope and was begun at the University of Minnesota, and a Canadian arm is being led by McGill University, U of A, and the University of Manitoba.
"This is a trial for people 18 years or age or older who are either exposed to somebody infected with COVID-19," says Ilan Schwartz, an infectious disease specialist and University of Alberta site-lead for the clinical trial. "So the eligible participants will be healthcare workers who have exposure to known cases without personal protective equipment and also household contacts of people who are diagnosed with COVID-19."
That study is looking to recruit up to 3,000 individuals to act as test subjects. Of those, 600 subjects will be enrolled in Alberta, with the remainder being recruited in Quebec, Manitoba and throughout the U.S. Researchers at additional Canadian provinces are also looking to join.
The drug for the trials is being supplied by the Canadian manufacturer Apotex. The trial is also supported by Purolator, which will ship the drug province-wide to participants at no cost and MC Dispatch, which will deliver in Calgary, Edmonton and adjacent communities.
More information about the clinical trial, including additional opportunities to take part in COVID-19 related research in Alberta, can also be found on the website bethecure.ca.
