Sarnia native Chantal Armali is a research coordinator with the Quality Efficacy Education and Safety in Transfusion (QUEST) research group in Toronto, helping coordinate the CONCOR-1 convalescent plasma clinical trial. (Submitted)
A North American clinical trial looking into treating COVID-19 with antibodies from recovered patients’ blood plasma will include patients at hospitals in Sarnia and London.
Sarnia’s Bluewater Health and London’s Victoria and University hospitals are among about 60 hospitals in Canada and New York State taking part in the randomized, open-label trial studying a possible treatment for the pandemic disease caused by the novel SAR-CoV-2 coronavirus.
A “crazy number” of plasma donors have been stepping forward and the first trial patients at Sunnybrook Hospital in Toronto – one of the lead participant hospitals – are expected to be recruited early next week, said Chantal Armali, a Sarnia native and research co-ordinator with the Quality Efficacy Education and Safety in Transfusion (QUEST) research group in Toronto.
Officials from McMaster University, Le Centre hospitalier universitaire Sainte-Justine and Sunnybrook are listed as the lead investigators in the groundbreaking CONCOR-1 study.
The first person to donate for the 1,200-patient trial through Canadian Blood Services was identified Wednesday, and another 10 to 20 have provided plasma – the liquid part of blood that carries cells and proteins throughout the body – via provincial blood supply agency Héma-Québec, said Armali, 30, who’s been helping work out the logistics for the study, including ethics approvals, protocols and grant applications.
That process usually takes months, she said, but teams have managed to fast track the needed approvals over one month to get the trial ready to begin.
Ethics approval was given for Bluewater Health Thursday, she said.
“Every site has basically made an emergency COVID-related ethics committee and we (have been) pushing those approvals through within a couple of days to a couple of weeks,” she said.
The Health Canada-regulated trial must follow very specific rules to make sure every site is trained properly and ready to go, she said.
“It’s been pretty hectic and crazy, and everyone’s basically just been working 24/7 to make this happen,” she said.
The hope is to have the trial completed within six to eight months – or sooner, if possible, she said.
The transfusion of convalescent plasma – taken from people who have recovered from an infection – has been used in treating other coronaviruses such as SARS and infections like Ebola, Armali said. China has also studied this approach for COVID-19 treatment, but with a very small sample size and without a comparator group.
“You can’t actually definitively say it works until you do a very specific, randomized trial of this magnitude,” she said.
About one-sixth to one-quarter of the study’s 1,200 patients will be from New York and the rest from Canada, Armali said.
The idea is to enter participant hospitals in phases – five to 10 at a time every week or two, she said. Recruiting all 1,200 trial participants will take about six months.
Participants must be 16 or older, in hospital and receiving supplemental oxygen for COVID-19.
Blood transfusions are infused over four hours while patients are monitored for adverse effects.
Two-thirds of participants get convalescent plasma while the remaining third don’t.
A similar CONCOR trial is also happening for youth under 16, Armali said
In a news release, Canadian Blood Services officials said donors must be younger than 67, be confirmed positive for COVID-19 by a laboratory test, and be fully recovered from the virus and symptom free for at least 28 days to participate, as well as meeting regular plasma donor requirements in Canada.
There are 11 donor sites across the country, including one in London.
If the treatment shows promise early, it can begin being adopted as the new standard of care, Armali said.
it’s unusual for smaller hospitals like Bluewater Health’s to participate in a clinical trial of this scope.
“I’m just really hoping this puts Sarnia on the map,” she said.
A charge technologist at Bluewater Health contacted Canadian Blood Services after hearing about convalescent plasma being used in a trial, and that message was forwarded to the QUEST team, Armali said.
Sarnia was identified as an appropriate site based on the number of COVID-19 positive cases here, she added. That number rose by three Thursday to 182.
The rate of COVID-19 infection per 100,000 population in Sarnia-Lambton as of April 29 was 137.4, the fifth highest in the province, according to Public Health Ontario.
Details about the CONCOR-1 trial are available at concor1.ca.
An online registry to donate for the trial through Canadian Blood Services is at blood.ca.