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Hyperimmune Plasma in Patients With COVID-19 Severe Infection

NCT04385043 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

Interventions

OTHER

plasma hyperimmune

patients will receive this as add on therapy

DRUG

standard therapy

patients will receive only standard therapy for Covid-19 infection

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

    collaborator OTHER

  • Azienda Sanitaria Provinciale Di Catanzaro

    collaborator OTHER

  • Annunziata Hospital, Cosenza, Italy

    collaborator OTHER

  • Azienda Ospedaliera Bianchi-Melacrino-Morelli

    collaborator OTHER

  • University of Catanzaro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-10-15
Completion
2021-05-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04385043 on ClinicalTrials.gov