Advisory - Clinical trial looking at the potential use of convalescent plasma to treat COVID-19

Summary

Product: Convalescent plasma (i.e., the component of blood known as plasma obtained from people who have recovered from COVID-19)
Issue: Some patients, their families and physicians have expressed interest about the use of convalescent plasma to treat COVID-19.
What to do: Patients and healthcare providers can learn more about a clinical trial in Canada. For information about convalescent plasma donor eligibility, people living outside Quebec can visit Canadian Blood Services' registry and people living in Quebec can visit Héma-Québec's website.

OTTAWA, May 1, 2020 /CNW/ - Health Canada recognizes that Canadians want fast access to new and promising health products related to COVID-19; however, health products must first be shown to be safe and effective. While some patients, their families and physicians are requesting that convalescent plasma be made available to treat COVID-19 in Canada, convalescent plasma has not been authorized as a treatment option. This means that the safety and effectiveness of convalescent plasma for treating COVID-19 have not been fully demonstrated at this time.

Convalescent plasma is the plasma of patients who have recovered from a virus, which generally means they have developed the antibodies necessary to fight off that virus. These antibodies develop in the body's plasma to help protect against future infection from the same virus. Plasma is the pale-yellow liquid component of blood that normally holds the blood cells in suspension. It makes up about 55% of the total volume of an individual's blood.

In Canada and across the world, clinical trials play an essential role in advancing research and the evaluation of investigational products to help respond to emerging health issues. To provide Canadians with the fastest access possible to health products related to COVID-19, Health Canada is expediting the review of any submissions related to COVID-19. In this light, Health Canada has authorized a nation-wide clinical trial (CONCOR-1 study) on the use of convalescent plasma to treat COVID-19. A clinical trial is the best way to obtain the necessary information systematically to determine whether convalescent plasma is a safe and effective treatment for COVID-19.

This study, known as CONCOR-1 study, is designed to assess the safety and effectiveness of administering convalescent plasma collected from donors who have recovered from COVID-19, to patients admitted to hospital with COVID-19, to decrease the risk of serious disease and prevent death. Canadian Blood Services and Héma-Québec are responsible for the collection and processing of donor plasma for this clinical trial. More than 40 hospitals across the country will participate in this national study.

Establishments that wish to collect convalescent plasma, must meet acceptable quality and safety requirements in accordance with the applicable Health Canada authorizations.

Information for potential plasma donors:

• For further details regarding plasma donor eligibility for people living outside Quebec, please visit the Canadian Blood Services' registry. Donors wishing to support the national clinical trial can also find more information at the Canadian Blood Services website.
• For further details regarding plasma donor eligibility for people living in Quebec, please contact Héma-Québec (1-888-666-4362). Donors wishing to support the national clinical trial can also find more information at the Héma-Québec web site.

Information for physicians:

• Physicians interested in using convalescent plasma to treat their patients are encouraged to contact the Hamilton Health Sciences Corporation, the clinical trial authorization holder. A list of all the COVID-19 clinical trials authorized by Health Canada, including this one, is available at Health Canada's website, Vaccines and treatments for COVID-19. If additional clinical trials on convalescent plasma are authorized in Canada, they will be added to this list.
• Physicians wishing to use convalescent plasma to treat patients that do not meet the inclusion criteria of the authorized clinical trial may consider single-patient emergency access by submitting a single-patient open-label clinical trial application to Health Canada. For further information, please contact the Biologic and Radiopharmaceuticals Drug Directorate's Office of Regulatory Affairs within Health Canada.

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SOURCE Health Canada

Media Inquiries: Health Canada, 613-957-2983, [email protected]; Public Inquiries: 1-833-784-4397