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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04622826

Enrollment

Registered

2020-11-10

Start date

2020-05-15

Completion date

2020-12-31

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19 Pneumonia

Keywords

covid-19 pneumonia, convalescent plasma, hyperimmune plasma

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.

Interventions

BIOLOGICALimmune plasma

immune covid 19 plasma infusion

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
ITU admission	up to 30 days	number of patients admitted to ITU after immune plasma transfusion
administration of O2	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)
hospital mortality	up to 90 days	number of subject deaths
immune plasma infusion adverse reaction	in the first 24-48 hours	number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Countries

Italy

Contacts

Primary Contactmirko lombardi

mirkolombardi9@gmail.com00393478546332

Backup Contactantonella vincenti

antonella.vincenti@uslnordovest.toscana.it003905854931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026