plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients

Phase 2

• Conditions: Covid-19 Pneumonia
• Interventions: Biological: immune plasma

• Registration Number: NCT04622826
• Lead Sponsor: Azienda USL Toscana Nord Ovest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-07
• Last Update Submitted: 2020-11-07
• Study First Posted: 2020-11-10
• Last Update Posted: 2020-11-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
sequential immune plasma infused patients	immune plasma	immune covid 19 plasma infusion

Primary Outcome Measures

Name	Time	Method
administration of O2	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	up to 90 days	number of subject deaths
ITU admission	up to 30 days	number of patients admitted to ITU after immune plasma transfusion
immune plasma infusion adverse reaction	in the first 24-48 hours	number of participants with treatment-related adverse events as assessed by CTCAE v4.0"

Trial Locations

Locations (1)

Ospedale delle Apuane; 🇮🇹 Massa, Toscana, Italy