When Donald Trump announced that convalescent plasma transfusions may be used on COVID-19 sufferers, you could be forgiven for thinking back to his suggestion that disinfectant could be injected into people to treat coronavirus.
Except, this decision to infuse COVID-19 patients in hospital with plasma from people who have recovered from the virus was, in fact, given emergency use authorisation by the US Food and Drug Administration.
This signalled a “major therapeutic breakthrough” – at least for the President, who said during a White House announcement that convalescent plasma “will save countless lives”.
It’s hoped that injecting seriously ill patients with blood plasma from recovered COVID-19 patients will boost weak immune systems with antibodies that may help fight the virus.
The key is to administer the plasma within the first three days of an infected person being admitted to hospital, the FDA said.
More than 72,000 patients in the US have already been infused with convalescent plasma as part of a COVID-19 research program run by the Mayo Clinic, a not-for-profit organisation comprising different types of medical professionals.
A study of the first 20,000 people, which is yet to be peer reviewed, concluded that it is safe to use convalescent plasma to treat COVID-19 patients who have been taken to hospital.
Thirteen of the 63 deaths that occurred in the study are suspected to have been related to the convalescent plasma transfusions.
There were also 146 severe adverse reactions to the treatment, which the researchers said can cause “life-threatening cardiac events and thrombotic events”.
Those figures relate to the first four hours of convalescent plasma being infused. A total of 1711 patients died within seven days of the transfusion, and there were 1136 other severe adverse events.
This “should not be considered a new standard of care” for treating COVID-19 patients, FDA chief scientist Denise Hinton said in a letter pertaining to the emergency authorisation.
She wrote: “Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
Alex Azar, Health and Human Services secretary, said people who have recovered from COVID-19 should consider donating their plasma.
Though what do our experts back home think about the FDA’s move? Is this something Australia should actually consider?
There are two clinical trials being run to assess just that.
One of them is the Australasian COVID-19 Trial (ASCOT) at the Doherty Institute, which Dr Steven Tong leads.
A Royal Melbourne Hospital infectious diseases physician, Dr Tong said convalescent plasma is a “promising therapy” for COVID-19 sufferers but should still be considered experimental.
“There has not been clear evidence from randomised controlled trials demonstrating a clinical benefit of convalescent plasma compared to the best standard of care,” Dr Tong said.
ASCOT is testing convalescent plasma on hospitalised patients who are not on a ventilator, while the Adaptive Platform Trial for Community-Acquired Pneumonia is focusing on patients in intensive-care units.
“In these trials, patients will be randomly assigned to the best standard of care or the best standard of care plus convalescent plasma,” Dr Tong said.
Australian Red Cross Lifeblood is supplying the convalescent plasma, he said.
Dr Alex Polyakov, epidemiologist and senior lecturer at the University of Melbourne, said there is a risk that patients will have a severe allergic or immunological reaction to someone else’s plasma being infused.
But, presumably, the FDA has reviewed all relevant data to date and decided that in extreme cases or emergency situations, the risks may be outweighed by the possible benefits, Dr Polyakov said.
Associate Professor Julian Elliott is executive director of the National COVID-19 Clinical Evidence Taskforce, which every day monitors evidence on all possible COVID-19 treatments.
“It’s absolutely essential for us to better understand the potential benefits of convalescent plasma and also the potential side effects,” he said, adding that it should only be used in the context of a clinical trial.
Professor Brian Oliver, head of UTS’s Respiratory Molecular Pathogenesis Group, said case reports – published when a treatment is given to one or a few patients outside of a clinical trial – about blood plasma and COVID-19 appear “promising”.
But as with any medical treatment, there are risks.
As long as doctors, patients and their families understand what they are, Professor Oliver said “I don’t think that it necessarily means that treatment shouldn’t be used”.
“For example, if I had a cancer that would kill me in six months, and there was a treatment that would either cure more or kill me – 50-50 chance – I think that I would take it.”