plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients
Primary Purpose
Covid-19 Pneumonia
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
immune plasma
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 Pneumonia focused on measuring covid-19 pneumonia, convalescent plasma, hyperimmune plasma
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
Sites / Locations
- Ospedale delle ApuaneRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sequential immune plasma infused patients
Arm Description
immune covid 19 plasma infusion
Outcomes
Primary Outcome Measures
ITU admission
number of patients admitted to ITU after immune plasma transfusion
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)
hospital mortality
number of subject deaths
immune plasma infusion adverse reaction
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Secondary Outcome Measures
Full Information
NCT ID
NCT04622826
First Posted
November 4, 2020
Last Updated
November 7, 2020
Sponsor
Azienda USL Toscana Nord Ovest
1. Study Identification
Unique Protocol Identification Number
NCT04622826
Brief Title
plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Toscana Nord Ovest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Pneumonia
Keywords
covid-19 pneumonia, convalescent plasma, hyperimmune plasma
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sequential immune plasma infused patients
Arm Type
Experimental
Arm Description
immune covid 19 plasma infusion
Intervention Type
Biological
Intervention Name(s)
immune plasma
Intervention Description
immune covid 19 plasma infusion
Primary Outcome Measure Information:
Title
ITU admission
Description
number of patients admitted to ITU after immune plasma transfusion
Time Frame
up to 30 days
Title
administration of O2
Description
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
Title
hospital mortality
Description
number of subject deaths
Time Frame
up to 90 days
Title
immune plasma infusion adverse reaction
Description
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Time Frame
in the first 24-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mirko lombardi
Phone
00393478546332
Email
mirkolombardi9@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
antonella vincenti
Phone
003905854931
Email
antonella.vincenti@uslnordovest.toscana.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
antonella vincenti
Organizational Affiliation
ospedale delle Apuane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale delle Apuane
City
Massa
State/Province
Toscana
ZIP/Postal Code
54033
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mirko lombardi
Phone
+393478546332
Email
mirkolombardi9@gmail.com
First Name & Middle Initial & Last Name & Degree
antonella vincenti
Phone
003905854931
Email
antonella.vincenti@uslnordovest.toscana.it
First Name & Middle Initial & Last Name & Degree
Antonella Vincenti
12. IPD Sharing Statement
Learn more about this trial
plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients
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