Out of an abundance of caution for the safety of study participants we have temporarily suspended enrolment into the Alberta HOPE COVID-19 Trial examining the effectiveness of hydroxychloroquine (HCQ) as an early intervention for COVID-19 until we can fully consider the results from this study and others that are ongoing. Followup and monitoring of patients enrolled in the trial will continue.
With treatment options for COVID-19 currently unclear, research is critical to find avenues that have the potential to help people battle the virus. University of Calgary and University of Alberta researchers are leading the Alberta HOPE COVID-19 trial, a provincewide study to investigate the effectiveness of the well-tolerated drug hydroxychloroquine (HCQ) as an early intervention for Albertans who test positive for COVID-19.
Led out of UCalgary in partnership with UAlberta, and with support from Alberta Health Services (AHS) Strategic Clinical Networks and the Government of Alberta, the randomized, double-blind, placebo-controlled clinical trial will recruit more than 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.
What is hydroxychloroquine?
Hydroxychloroquine is a drug that has been in use for decades as a treatment for malaria, and more recently for patients with autoimmune diseases such as lupus and rheumatoid arthritis. Laboratory studies also suggest that the drug, recently touted by U.S. President Donald Trump and some other world leaders as a potential treatment, may be helpful against the COVID-19 virus, but there have only been very small studies suggesting clinical benefit.
What will the AB HOPE COVID-19 clinical trial involve?
"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 Luanne Metz, principal investigator on the study, acting facility medical director of 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 SARS-CoV-2, the virus that causes COVID-19. Recruits also have to be within 12 days 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 Michael Hill, 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.
How do I participate?
AHS staff will obtain permission from individuals with positive COVID-19 tests to provide their contact information to the researchers. Consenting participants will be screened for safety and eligibility. The treatment will then be delivered to their door, anywhere in Alberta. Receipt of the treatment will be witnessed by the courier and confirmed by phone. Participants will then be followed up with by phone on Days 7 and 30 of starting the treatment.
Additional information can be found at hopecovid.ca and Be the Cure.
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.
UAlberta partners
Researchers are seeking approval to ask participants in the Alberta HOPE COVID-19 trial whether other household members, who have not tested positive for COVID-19, may be interested in joining a different study. U of A researchers Lawrence Richer and Ilan Schwartz are investigating whether HCQ may be effective in slowing or even preventing the transmission of COVID-19.
Richer is director of the Northern Alberta Clinical Trials & Research Centre, associate dean of clinical research in the U of A's Faculty of Medicine & Dentistry, and associate director of the Women and Children's Health Research Institute. He is a pediatric neurologist and professor in the Department of Pediatrics at the U of A.
"This prevention trial is for people who are exposed to somebody infected with COVID-19," says Schwartz, an infectious disease specialist, assistant professor of medicine and U of A site-lead for the clinical trial. "Eligible participants will be adults-who don't have symptoms and have not tested positive for COVID-19-who live with someone diagnosed with COVID-19, and health-care workers who have exposure to known cases."
This study will look at whether the medication, when administered within a few days of a person's first exposure, can prevent infection from occurring and whether it can prevent progression to a disease requiring hospitalization. Half the participants will receive HQC and the other half will receive a placebo.
"Clinical trials like these will give health-care professionals more evidence to determine how best to care for patients," says Kathryn Todd, AHS vice-president of provincial clinical excellence. "AHS is rallying alongside its academic partners at the universities of Calgary and Alberta to help leverage research in the response to this global pandemic."