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

Azienda USL Toscana Nord Ovest

Status and phase: Unknown; Phase 2

Conditions: Covid-19 Pneumonia

Treatments: Biological: immune plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04622826

ATNONordOvest

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

sequential immune plasma infused patients

Experimental group

Description:

immune covid 19 plasma infusion

Treatment:

Biological: immune plasma