Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid-19 Pneumonia
- Sponsor
- Azienda USL Toscana Nord Ovest
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- administration of O2
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
mirko lombardi
consultant
Azienda USL Toscana Nord Ovest
Eligibility Criteria
Inclusion Criteria
- •\> 18 years
- •hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
- •informed consent for plasma infusion
- •informed consent to blood samples storing for future studies.
Exclusion Criteria
- •pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study
- •immunoglobulin infusion in the last month
- •contraindication to transfusion or previous adverse reaction
Outcomes
Primary Outcomes
administration of O2
Time Frame: up to 30 days
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)
hospital mortality
Time Frame: up to 90 days
number of subject deaths
ITU admission
Time Frame: up to 30 days
number of patients admitted to ITU after immune plasma transfusion
immune plasma infusion adverse reaction
Time Frame: in the first 24-48 hours
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"