Hyperimmune Plasma in Patients With COVID-19 Severe Infection

• Status: Recruiting
• Trial end date: 2021-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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, and has also been used during the SARS (2002-2003) and Ebola (2014-2016) viral epidemy for which there were no alternative immunoprophylactic or therapeutic interventions.

To date, there are not proven etiological therapies for 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.

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Catanzaro
• Collaborators: Annunziata Hospital, Cosenza, Italy; Azienda Ospedaliera Bianchi-Melacrino-Morelli; Azienda Ospedaliera Policlinico "Mater Domini"; Azienda Ospedaliera Universitaria Mater Domini, Catanzaro; Azienda Sanitaria Provinciale Di Catanzaro

Criteria

Inclusion Criteria:

• inclusion criteria for donors: null-gravid, with a negative history of transfusion of blood components; possibility to sign the informed consent

• inclusion criteria for Covid-19 infected patients: serious Covid-19 infection, possibility to sign the informed consent (also through the legal tutor)

Exclusion Criteria:

• exclusion criteria for donors: presence of pregnancy, recent history of transfusion of blood components, < 18 years.

• exclusion criteria for Covid-19 infected patients: non serious Covid-19 infection, impossibility to sign the informed consent (also through the legal tutor)