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Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patientsWiki
Developed by Shray Alag
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There is one clinical trial.
Clinical Trials
The 2019 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID
19), which originated in Wuhan, China, has become a major concern all over the world.
Convalescent plasma or immunoglobulins have been used as a last resort to improve the
survival rate of patients with SARS whose condition continued to deteriorate despite any
attempted treatment.. Moreover, several studies showed a shorter hospital stay and lower
mortality in patients treated with convalescent plasma than those who were not treated with
convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered
from viral infections can be used effectively as a treatment of patients with active disease.
The use of solutions enriched of antiviral antibodies has several important advantages over
the convalescent plasma including the high level of neutralizing antibodies supplied.
Plasma-exchange is expensive and requires large volumes of substitution fluid. Albumin is
better tolerated and less expensive, but exchanges using albumin solutions increase the risk
of bleeding because of progressive coagulation factor depletion. With either albumin or fresh
frozen plasma, increasing the risk of cardiovascular instability in the plasma donor and in
the recipient, which can be detrimental in a critically ill patient with COVID 19 pneumonia.
The aforementioned limitations of plasma therapy can be overcome by using selective apheresis
methods, such as double-filtration plasmapheresis (DFPP).DFPP is a modality of plasma
purification that performs an initial plasma separation from blood, and the subsequent
separation of specific molecules, on the basis of their specific molecular weight (cut-off),
by using a fractionation filter. The Fractionation Filter 2A20, because of its membrane
sieving cut-off, retains larger molecules and returns plasma along with smaller molecules to
the circulation, including the major part of the albumin. The selection of the membrane 2A20
is related to the appropriate Sieving Coefficient for IgG that allows to efficiently collect
antibodies from patients which are recovered from COVID-19, with negligible fluid losses and
limited removal of albumin. The total amount of antibodies obtained during one DFPP session
exceeds by three to four times the total amount provided to recipients with one unit of
plasma obtained during one plasma-exchange session from one COVID-19 convalescent donor. This
should result in more effective viral inhibition and larger benefit for the patient achieved
with one unit of enriched immunoglobulin solution obtained with DFPP than with one unit of
plasma obtained with plasma exchange.
These observations provide the background for a pilot study aimed to explore whether the
infusion of antibodies obtained with one single DFPP procedure from voluntary convalescent
donors could offer an effective and safe therapeutic option for critically ill patients with
severe coronavirus (COVID-19) pneumonia requiring mechanical ventilation.