WHO opposes the use of convalescent plasma to treat COVID-19 patients
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WHO opposes the use of convalescent plasma to treat COVID-19 patients.
On December 6, the World Health Organization stated that it is not recommended to use convalescent plasma from COVID-19 patients to treat patients with mild or severe COVID-19.
However, some American experts believe that some patients with COVID-19 can benefit from the plasma of survivors.
The WHO stated:
This recommendation is based on a review of 16 randomized controlled trials (RCTs) and a “meta-analysis on COVID- 19 antibodies and cell therapies”, and added in a statement:
Although it is initially promising for the treatment of COVID-19, existing evidence shows that convalescent plasma can neither improve the survival rate of patients with COVID-19, nor can it reduce the need for ventilators in patients with COVID-19, and the use of convalescent plasma is expensive and time-consuming.
Therefore, WHO strongly opposes the use of convalescent plasma in non-critically ill patients, and recommends not to use convalescent plasma in severe and critically ill patients, unless it is a randomized controlled trial (RCT) .
The WHO stated in the British Medical Journal (BMJ):
Most importantly, given that the recovery period plasma is not significantly helpful for the treatment of severely ill patients with COVID-19 disease, the Guideline Development Group (GDG) believes that the relevant resources (including time and cost) invested in the recovery period plasma management are unreasonable.
This statement is based on recently published data. The data shows that although the recovery period plasma has been proven to be safe in general, it has not shown efficacy in randomized controlled trials in some large outpatient patients.
The data source includes the United Kingdom A trial on the mortality of inpatients with the COVID-19 published in The Lancet in May, and a trial on the mortality of outpatients in the New England Journal of Medicine published in August.
In the results published in the New England Journal of Medicine (NEJM) , a trial funded by the National Institutes of Health (NIH) enrolled more than 500 patients who were randomized to receive convalescent plasma or placebo within one week of the onset of symptoms.
77 patients in the convalescent plasma group (30%) and 81 patients in the placebo group (31.9%) had some degree of COVID-19 infection.
Five patients in the plasma group and one patient in the placebo group died. The trial was forced to stop in early February due to lack of effectiveness.
However, experts still believe that convalescent plasma may be beneficial to patients with COVID-19 in some cases, that is, when the detection time is early enough and the antibody titer is high enough (as Peter Marks, director of the FDA Biological Products Evaluation and Research Center, said) , Or for those whose immune system may be defective to some degree.
Shmuel Shoham, associate professor of medicine at Johns Hopkins University, said:
Based on the available data, I disagree with this conclusion. If used at the right time and with a sufficiently high titer, COVID-19 Convalescent Plasma (CCP) is effective and safe.
The widespread use of convalescent plasma provides a treatment option for areas where antibodies are not easily available. The Johns Hopkins University outpatient study will provide more data soon.
The FDA still insists on the emergency use authorization of convalescent plasma.
In February last year, it narrowed its authorized use to high-price pharmaceutical units and hospitalized patients in the early stages of illness. Whether the new WHO recommendations will change the FDA’s emergency use authorization remains to be seen.
An FDA spokesperson said:
We do not comment on the WHO statement, and the FDA’s emergency authorization for the use of convalescent plasma is still valid.
The FDA reissued the emergency use authorization on March 9, 2021, and revised it in June. The FDA did not collect data on receiving convalescent plasma treatment after emergency use authorization.
Approximately 70,000 people received convalescent plasma treatment under an expanded access program of Mayo Clinic that the FDA helped establish.
Jeff Henderson, associate professor of medicine at Washington University School of Medicine in St. Louis, said:
In the past year and a half, people have learned a lot about the pathogenesis of COVID-19 pneumonia.
According to related treatments, we have learned about the pathogenesis of COVID-19 pneumonia from the early stage of virus replication to the later stage of inflammation-related tissue damage.
With this in mind, in the early stages of the disease, when high-titer COVID-19 recovery plasma is administered to mild to moderate patients, relevant studies have detected efficacy signals.
References:
1.https://endpts.com/who-recommends-against-the-use-of-convalescent-plasma-for-covid-19/
WHO opposes the use of convalescent plasma to treat COVID-19 patients
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