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

November 7, 2020 updated by: mirko lombardi, Azienda USL Toscana Nord Ovest

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequential immune plasma infused patients
immune covid 19 plasma infusion
Biological: immune plasma
immune covid 19 plasma infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ITU admission
Time Frame: up to 30 days
number of patients admitted to ITU after immune plasma transfusion
up to 30 days
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)
up to 30 days
hospital mortality
Time Frame: up to 90 days
number of subject deaths
up to 90 days
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"
in the first 24-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Toscana Nord Ovest

Investigators

  • Principal Investigator: antonella vincenti, Ospedale delle Apuane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 7, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATNONordOvest

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe