Efforts are under way to connect scientists with eligible Canadians to participate in clinical trials as research teams race to find ways of treating and preventing COVID-19.
Even in the best of times, recruiting participants for clinical trials is a challenging and lengthy process that generally depends on doctors referring patients to the specific research centre conducting a trial, says Ramy Saleh, a physician with the McGill University Health Centre.
The vast majority of clinical trials are not completed on time, which can cost the biopharmaceutical industry millions of dollars for each day they are delayed, says Gerald Minuk, a professor of medicine, pharmacology and therapeutics at the University of Manitoba.
In the current pandemic, these delays can also cost lives, he says.
To help speed up recruitment and accelerate the completion of clinical trials, Dr. Minuk, who is also president and chief executive of Refuah Solutions Inc., says his company is donating the use of its app to research teams conducting COVID-19 clinical trials. The app, called PI-Enroll, is designed to provide doctors the information they need on their mobile devices to identify individuals who may qualify for a trial and discuss the trial with them. It also allows doctors to immediately notify the trial’s study co-ordinator or study nurse that they have a potential candidate and it allows researchers to communicate with each other, Dr. Minuk says.
To modify the app for COVID-19 clinical trials, the company added a feature that would allow laboratories that get positive tests results to automatically alert research investigators, he says.
Meanwhile for members of the public, Dr. Saleh has created a website, called Covidtrials.ca, to match Canadians interested in participating in clinical trials with the research teams conducting them. The website allows people to look through all of the active clinical trials related to COVID-19 that are approved by Health Canada and to register if they wish to volunteer.
The site then matches registrants with available trials taking place in their area, Dr. Saleh says. If no trial is taking place nearby, it will match them as soon as one opens up, he says. The site collects registrants’ information on a secure database and a system alerts the principle investigators so that they can contact volunteers directly, he explains. That way, would-be participants do not have to seek out and contact researchers themselves, he says.
“Given that health care providers are overwhelmed, we don’t want thousands of patients calling numbers and hoping someone will answer,” he says.
As of Friday, Health Canada had published a list of 16 approved clinical trials. Here’s a sampling:
Postexposure prophylaxis or pre-emptive therapy using hydroxychloroquine
This study, involving researchers from McGill University, University of Manitoba, University of Alberta and University of Minnesota, is testing whether hydroxychloroquine can prevent the development of COVID-19 after someone has been exposed to the new coronavirus. It is also testing whether early treatment with hydroxycholoroquine can prevent those with COVID-19 from getting worse.
Researchers are looking for participants who are over the age of 18 and who either have COVID-19 or have been exposed to someone with the disease.
Individuals can enroll through the study’s website: covid-19research.ca.
This study, conducted by the Montreal Heart Institute and New York University, is testing whether colchicine, an anti-inflammatory medication, can reduce complications related to COVID-19 by preventing an overreaction of the immune system, called an inflammatory storm.
Researchers are recruiting participants 40 years and older, who have tested positive for COVID-19, are not in hospital, and are willing to take the drug or a placebo for 30 days.
Those interested can find out more about the study through its website colcorona.org.
Lopinavir/ritonavir (CATCO – Canadian Arm of the Solidarity Trial)
This study, part of an international World Health Organization trial called “solidarity," will test whether lopinavir/ritonavir, a combination of antiviral drugs used to treat HIV, can help patients hospitalized with COVID-19.
Researchers are enrolling patients older than six months of age, who are in hospital at a participating centre. These centres include hospitals in Vancouver, Ottawa, Toronto, Montreal and Quebec City. More information can be found here: clinicaltrials.gov/ct2/show/NCT04330690
Convalescent plasma (CONCOR – Convalescent Plasma for COVID-19 Research)
Though not yet listed among Health Canada’s approved clinical trials, this study, involving McMaster University, University of Montreal and University of Toronto and their partners, will test whether the plasma component of blood from individuals who have recovered COVID-19 can be used to help patients in hospital with the disease.
Canadian Blood Services and Héma-Québec will collect and manage the plasma donations. Those interested in participating can find out more information through the Canadian Blood Services website: blood.ca/en/convalescentplasma
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