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Chick-News.com Poultry Industry News, Comments and more by Simon M. Shane

Doubt Concerning the Efficacy of Convalescent Plasma for COVID-19 Patients

08/30/2020

Despite the much-heralded announcement on Sunday, August 23rd that convalescent plasma from patients recovered from COVID-19 was a groundbreaking therapy for COVID-19, specialists in infectious diseases and immunology have questioned the value of antibodies.  The Administration has previous touted hydroxychloroquine as a panacea, again without scientific support and justification and it now appears that convalescent plasma is the new "miracle".

 

In an opinion article in the New England Journal of Medicine, editor Dr. Paul Sax noted that the justification for accepting that convalescent plasma was highly effective and was able to “reduce mortality by 35 percent” was based on incorrect interpretation of preliminary data.  Randomized trials of convalescent plasma have in fact been disappointing and the claim that this approach was "powerful therapy" and "had an incredible rate of success" is unsubstantiated at best.

 

The NIH meta analysis involved a comparison among groups of patients that received convalescent plasma with either high or low antibody titer.  There was no negative control and comparisons were confounded by other treatments and supportive therapy administered to the participants.  A careful examination of data and statistical analysis did not support the Administration assertions apparently derived from unpublished studies.

 

What is disconcerting is the fact that Dr. Stephen Hahn, the Commissioner of the FDA, responsible for approval of convalescent plasma to treat COVID-19 was apparently either unaware of the discrepancy or failed to interpret data for which he subsequently apologized. Notwithstanding the FDA has extended Emergency–use authorization for hyperimmune plasma as a therapy. There is obvious concern over the potential for raising false hopes based on incomplete and non-peer reviewed data.

 

In his comments, Dr. Sax noted "I have not heard from a single infectious disease specialist who believes that approval of convalescent plasma was supported by existing data".  Sax continued "convalescent plasma may work to help people with COVID-19, but if it does, we do not know how much or who are the most likely to benefit or how to select the right donors".  Sax, representing the medical profession, notes that the evaluation of convalescent plasma comprised "70,000 anecdotes tied together by individual reports and separate observational studies".  Sax along with reputable and experienced members of the medical community recognizes the need for randomized controlled clinical trials on hyperimmune plasma currently being performed in a number of nations.


 
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