A Phase 2 interventional study of immune plasma in Covid-19 Pneumonia, sponsored by Azienda USL Toscana Nord Ovest. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Azienda USL Toscana Nord Ovest · Phase 2, Interventional, and Prevention
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.
Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Azienda USL Toscana Nord Ovest is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study
contraindication to transfusion or previous adverse reaction
immune covid 19 plasma infusion
Biological: immune plasma
immune covid 19 plasma infusion
ITU admission
number of patients admitted to ITU after immune plasma transfusion
Time frame: up to 30 days
administration of O2
O2 support will be monitored and reported in its various modes of administration (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, mechanical ventilation)
Time frame: up to 30 days
hospital mortality
number of subject deaths
Time frame: up to 90 days
immune plasma infusion adverse reaction
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Time frame: in the first 24-48 hours
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Azienda USL Toscana Nord Ovest