Hyperimmune Plasma in Patients With COVID-19 Severe Infection

Passive immunotherapy through plasma infusion of convalescent subjects - convalescent plasma
- or "hyperimmune" plasma was one of the most widespread and effective anti-infective
treatments in the pre-antibiotic era and one of the founding pillars of immunology.
Immunoprophylaxis represents an irreplaceable protection for post-exposure prevention of
several viral infections such as measles, hepatitis B and rabies. Recently, the use of
convalescent plasma for therapeutic purposes has been re-evaluated during the SARS
(2002-2003) and Ebola (2014-2016) epidemic caused by serious viral infections for which there
were no immunoprophylactic or therapeutic interventions. alternative. The results of these
experimental interventions, despite the limited number and the often anecdotal character,
have shown promise even if not conclusive. In the case of SARS, the first human respiratory
disease caused by a Coronavirus, treatment with convalescent plasma was associated with a 23%
reduction in mortality and with the best results if administered at an early stage of the
disease. In addition, all the evidence available in the literature has confirmed the safety
of convalescent plasma treatments, in line with what has already been observed in the
transfusion practice with Fresh Frozen Plasma.

As is known, there are currently no proven etiological therapies to combat SARS-CoV-2
infection, the agent responsible for the disease called Covid-19. Among those subjected to
clinical studies during the current epidemic in China, hyperimmune plasma appears to be one
of the most rational and promising.

Waiting for the numerous clinical trials underway especially in Asia and accessible on the
website http://apps.who.int/trialsearch/default.aspx to define if and to what extent this
therapeutic contribution improves the prognosis of patients suffering from serious forms of
infections from SARS-Co-2, the clinical guidelines of the People's Republic of China, already
provide for the use of hyperimmune plasma with the indication "in rapidly progressive
disease, severe and very severe form" and by the FDA .

As regards the technical protocols for the preparation of hyperimmune plasma for clinical use
in the literature, precise references are available in particular for the preparation,
qualification, viral inactivation and dosage of hyperimmune plasma for the treatment of viral
epidemic infections such as MERS and Ebola and which can also be validated and used for the
preparation of plasma from convalescent patients for Covid-19.

From the above, the objective of this study will be to evaluate the efficacy and safety of
the hyperimmune plasma administered add-on to the anti-Covid-19 treatment (standard therapy)
according to clinical practice in patients with severe Covid-19 infection, compared to
patients with severe Covid-19 infection treated only with standard therapy.