May 25, 2020 – Out of an abundance of caution for the safety of study participants, the University of Calgary has temporarily suspended enrolment into the Alberta HOPE COVID-19 Trial looking into the effectiveness of hydroxychloroquine (HCQ) as an early intervention for COVID-19 until results from a WHO study and others that are ongoing can be reviewed. Follow-up and monitoring of patients enrolled in the trial will continue. We’ll keep you informed, posting updates as we receive more information.
Alberta Innovates has invested in a new provincial study to determine whether the drug hydroxychloroquine (HCQ) can prevent hospitalization for high-risk patients who have tested positive for COVID-19.
The study, called Alberta HOPE COVID-19 at the universities of Calgary and Alberta, will examine the effectiveness of HCQ as an intervention for COVID-19. Alberta Innovates has joined the Government of Alberta, University of Calgary, Calgary Health Trust and Alberta Health Services in funding the research.
Treatment options for COVID-19 are unclear and research is critical to finding new avenues to help people battle the virus. HCQ is a well-tolerated drug primarily used in the treatment of malaria, lupus and rheumatoid arthritis. So far there is limited evidence to support the use of HCQ to treat those with COVID-19.
“Alberta is one of the few jurisdictions in Canada that has the ability to quickly generate new knowledge related to HCQ on a provincial scale,” says Tim Murphy, Vice President of Health Innovation at Alberta Innovates.
Having a single health authority makes it possible to launch a provincewide clinical trial such as this, Murphy notes. It is also made easier thanks to a series of critical infrastructure investments by Alberta Innovates that increased clinicians’ access to health data, allowing them to better develop outcome measures and clinical trials aimed at practical solutions, he adds.
“Alberta Innovates is thrilled those past data infrastructure investments will be leveraged in this clinical trial during these uncertain and turbulent times. As the saying goes, the time to start thinking about building the firehall is not when your house is on fire.”
The randomized, double-blind, placebo-controlled clinical trial Alberta HOPE COVID-19 will recruit over 1,600 Albertans who have recently tested positive for COVID-19 to determine whether a prescribed five-day treatment of HCQ can prevent hospitalization for those at highest risk of developing a severe illness.
[University of Alberta, Faculty of Medicine & Dentistry story]
[Excerpts from University of Calgary news release]:
“We will be targeting Albertans who have an underlying medical condition which has proven to contribute to the worsening of symptoms, and eventual hospitalization,” says Dr. Luanne Metz, MD, principal investigator on the study, acting facility medical director, Foothills Medical Centre, and professor at the Cumming School of Medicine(CSM). “Managing Albertans entirely in the community will ensure that hospital resources are available for those who are severely ill and others who require medical attention for conditions other than COVID-19.”
The study will recruit Albertans who are at home, can swallow a pill and can begin the treatment protocol within 96 hours of testing positive for the SARS-CoV-2, the virus that causes COVID-19. They also have to be within a 12-day window of the first reported symptoms of the virus.
“Alberta HOPE COVID-19 is an Alberta-only unique trial, designed, run and funded in Alberta,” says Dr. Michael Hill, MD, study co-lead in Calgary and professor at the CSM. “The clinical trials team at the university and AHS are highly experienced and dedicated to this effort. Thanks to our proven experience we were able to get this trial up and running at an unprecedented pace.”
The drug and placebo for the trial are being donated by Canadian manufacturer Apotex. Laboratory studies also suggest that HCQ may be helpful against the COVID-19 virus, however, there have only been very small studies suggesting clinical benefit.
See the study requirements for the Alberta Hope COVID-19 Trial.