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

NCT ID: NCT04622826

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Covid-19 Pneumonia

Keywords

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covid-19 pneumonia convalescent plasma hyperimmune plasma

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sequential immune plasma infused patients

immune covid 19 plasma infusion

Group Type EXPERIMENTAL

immune plasma

Intervention Type BIOLOGICAL

immune covid 19 plasma infusion

Interventions

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immune plasma

immune covid 19 plasma infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role lead

Responsible Party

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mirko lombardi

consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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antonella vincenti

Role: PRINCIPAL_INVESTIGATOR

ospedale delle Apuane

Locations

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Ospedale delle Apuane

Massa, Tuscany, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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mirko lombardi

Role: CONTACT

Phone: 00393478546332

Email: [email protected]

antonella vincenti

Role: CONTACT

Phone: 003905854931

Email: [email protected]

Facility Contacts

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mirko lombardi

Role: primary

antonella vincenti

Role: backup

Other Identifiers

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ATNONordOvest

Identifier Type: -

Identifier Source: org_study_id