The Globe and Mail - 08.04.2020

A10 FOLIO O THEGLOBEANDMAIL | WEDNESDAY,APRIL8,

But health officials and epidemiologists
say there is also a growing requirement for
serological tests that require only a drop of
blood and that can reveal if someone has
had COVID-19 at some point in the past.
These kinds of tests are sensitive to the an-
tibodies that the immune system produces
in response to a viral attack, which are ex-
pected to linger for many months after the
virus itself has been cleared from the body.
If made both reliable and widely avail-
able, such tests could be used to identify
who has already had the coronavirus. The
test may also indicate that someone has
immunity from the coronavirus, but that
depends on whether the antibodies that
are detected are an effective deterrent
against reinfection. In that case, large-scale
testing would provide insights into the
changing level of immunity within the
general population.
“We want to measure, with thousands of
samples, what’s happening over time,”
said Jim Woodgett, the institute’s director.
The arrival of the new platform could
prove crucial while efforts to make com-
mercial serological tests more widely avail-
able in Canada remain in a regulatory
holding pattern.
At latest count, Health Canada has re-
ceived 16 applications from companies
looking to have serological tests approved,
but none has yet been reviewed.
Vivian Zhang, a sales specialist with one

of the applicants, Biogate Laboratories Ltd.

of Burnaby, B.C., said the company is hop-

ing for approval of its made-in-Canada ser-

ological test that provides a simple yes or

no to the presence of antibodies within five

to 10 minutes. The test can be used either

by individual consumers or by health clin-

ics and labs.

She added the company is now provid-

ing additional information in response to

questions from Health Canada.

“We hope Health Canada can approve it

as soon as possible as the situation in Can-

ada continues to be urgent,” Ms. Zhang

said.

In a statement, Health Canada said it is

working with researchers at the National

Microbiology Laboratory in Winnipeg,

among others, “so that we can have confi-

dence in the test results.”

Serological tests are now being used in

China and Singapore. On Thursday, the

U.S. Food and Drug Administration ap-

proved a serological test made by Cellex, a

North Carolina-based biotech company,

for use in the United States.

Where the Sinai Health effort differs

from commercial test suppliers is in its po-

tential to provide a view of infection rates

within a large group of subjects over time.

Because it employs a robotic system, it can

ensure consistent specimen handling and

quality control while cutting down on the

supplies and staff resources needed to sur-

vey a large group of subjects.

The platform’s most important raw ma-

terial is a large supply of coronavirus pro-

teins, which are used to detect when CO-

VID-19 antibodies are present in blood

Tests:

Robotic

system

could

ensure

consistent

specimen

handling

Ifmadebothreliableandwidelyavailable,serologicaltestscouldbeusedto

identifywhohasalreadyhadthecoronavirus,andmayalsoindicatewhether

someonehasimmunityfromthevirus.

Anne-ClaudeGingras,aseniorinvestigatoratSinaiHealth’s

Lunenfeld-TanenbaumResearchInstituteinToronto,isseenonMonday.

Dr.Gingrasisco-leaderoftheefforttotailoraroboticsystemtoprocess

testsonalargescale.

FROMA

A team of blood transfusion experts from
across Canada is planning the world’s
largest clinical trial of a potential treat-
ment for COVID-19.
The study, which will involve 1,000 pa-
tients from across the country, will include
at least 40 Canadian hospitals, and is being
overseen by doctors from the University of
Montreal, University of Ottawa, University
of Toronto, McMaster and the University
of British Columbia, among other schools.
The experimental treatment involves
injecting antibody-rich plasma from pa-
tients who have recovered from the virus
into those who are still infected. This ap-
proach has only been tried in small trials
in China, Singapore, South Korea and the
U.S. It is part of a global race to find a treat-
ment for the disease, with researchers also
focusing on antivirals and medications
used to treat malaria.
Donation centres across Canada will ex-
tract plasma, a straw-yellow liquid compo-
nent of blood, from recovered patients
and test that it has a certain minimum
number of antibodies to be considered
useful as an immunotherapy. Known as
convalescent plasma, the material will
then be frozen, sent to participating hospi-
tals and infused into a critical patient to
see if it can help treat their illness. In the
early stages of infection, the body doesn’t
produce the antibodies needed to fight off
the novel coronavirus, according to Dr. Do-
nald Arnold, a hematologist at McMaster
University who is leading the trial.
“The theory is that people who have re-
covered from COVID infection may have
antibodies to fight the virus,” Dr. Arnold
said.
Canada’s two blood suppliers, Canadian
Blood Services and Héma-Québec, will be
managing donations from those who have
fully recovered from COVID-19.
Late last month, a small Chinese study
of five ventilated patients suggested the
technique could be used to temper the se-
verity of coronavirus. Three of the five pa-
tients were able to be weaned off ventila-

tors days after receiving plasma. During

the SARS outbreak, 80 patients were treat-

ed with convalescent plasma. A review of

that study showed that the earlier the

transfusion, the better the outcome of the

patient. None of the patients in that trial

experienced adverse reactions to the treat-

ment.

In late March, U.S. regulators allowed

doctors to begin collecting recovered pa-

tients’ plasma for emergency use. Dr. Ar-

nold, the lead of the Canadian trial, admits

that the treatment is a “Hail Mary.” While

transfusion therapies aren’t typically risky

for the patient, there is a chance this trial

won’t have a significant impact in treating

COVID-19, instead draining resources and

time.

Dr. Michael Joyner of the Mayo Clinic,

which will run the American national sup-

ply chain of plasma, said on Wednesday

that their findings will be shared with oth-

er countries in virtual real time.

The plan for the Canadian trial came to-

gether in just days. A group of a dozen he-

matologists and scientists joined a Zoom

call on March 29 and worked out a plan – a

process that usually takes between six

months and a year for a typical trial, ac-

cording to Dr. Arnold.

The researchers soon learned that a par-

allel trial was being developed in Quebec.

The following day, they merged into one

large unit, with different participating in-

stitutions tackling potential subdivisions

of research. Dr. Arnold said that by April 1,

nearly every hospital in the country treat-

ing COVID-19 patients had signed on to

participate.

Dr. Dana Devine, Canadian Blood Ser-

vices’ head scientist, said that while China

is now collecting donations from multiple

sites, there hasn’t yet been a large patient

study with a control group – meaning that

certain patients don’t receive plasma –

which is the gold standard for clinical trials

and would be key in determining the wide-

spread efficacy of this treatment.

She said that the group is now finalizing

funding and infrastructure while Canada’s

two blood banks work with provincial

health ministries to contact all recovered

positive COVID-19 cases about donating.

Donating plasma is no different than

conventional blood donation, according

to Dr. Devine, and takes about 45 minutes.

She said each donor’s plasma will be stud-

ied for its virus-fighting viability.

All patients who are hospitalized and

need oxygen will be able to sign up for the

trial.

“It’s a flip of a coin – two-thirds of pa-

tients will get the antibody-rich blood,

with the other third being a control

group,” Dr. Arnold said. The control group

would receive standard care.

The trial could be completed in as little

as three months. Dr. Arnold said they are

realistically looking at six to 10 months be-

fore they have definitive results.

“The challenge is to get to an answer as

quickly as possible so that we can start us-

ing this product if it’s truly effective, or re-

alize it’s not and stop using it,” Dr. Arnold

said.

Dr. Rulan Parekh of SickKids Hospital in

Toronto said there will also be a pediatric

component to the trial, and that there will

be multiple concurrent studies, including

those to determine longer-term immu-

notherapies.

“I’ll be doing a larger study, with Dr. De-

vine, of donors to understand their immu-

nity,” she said. “We also hope to get viable

candidates to help create a large reposito-

ry, so scientists can use their blood to

think about immunotherapies.” Those

could include a treatment that could help

Canadabeginsclinicaltrialofexperimentalvirustreatment

usingplasmafromrecoveredindividuals

Right:Dr.KongYuefeng,arecoveredCOVID-19patientwhohaspassedhis14-day

quarantine,donatesplasmaatthebloodcentreinWuhan,inChina’sHubeiprovince,

inFebruary.Chinaiscollectingplasmafrompatientsatmultiplesites,whilesimilar

trialshavebeenconductedinSingapore,SouthKoreaandtheU.S.CHINATOPIXVIAAP

Above:RecoveredCOVID-19patientTiffanyPinckney,seenearlierthismonthin

NewYork,isoneofthefirstU.S.donorsofconvalescentplasmaforan

experimentaltreatment.MARSHALLRITZELL/AP

MICHAELDOYLE