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

Covid-19 Pneumonia Clinical Trial

Official title:

Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622826
• Other study ID #: ATNONordOvest
• Status: Recruiting
• Phase: Phase 2
• Start date: May 15, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2020
• Source: Azienda USL Toscana Nord Ovest
• Contact: mirko lombardi
• Phone: 00393478546332
• Email: mirkolombardi9[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19 Pneumonia
• Pneumonia

Intervention

Biological:
• immune plasma
immune covid 19 plasma infusion

Locations

Country	Name	City	State
Italy	Ospedale delle Apuane	Massa	Toscana

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Toscana Nord Ovest

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ITU admission	number of patients admitted to ITU after immune plasma transfusion	up to 30 days
Primary	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)	up to 30 days
Primary	hospital mortality	number of subject deaths	up to 90 days
Primary	immune plasma infusion adverse reaction	number of participants with treatment-related adverse events as assessed by CTCAE v4.0"	in the first 24-48 hours