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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedFirst Submitted
Initial submission to the registry
November 4, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 10, 2020
November 1, 2020
8 months
November 4, 2020
November 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
ITU admission
number of patients admitted to ITU after immune plasma transfusion
up to 30 days
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)
up to 30 days
hospital mortality
number of subject deaths
up to 90 days
immune plasma infusion adverse reaction
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
in the first 24-48 hours
Study Arms (1)
sequential immune plasma infused patients
EXPERIMENTALimmune covid 19 plasma infusion
Interventions
Eligibility Criteria
You may qualify if:
- \> 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale delle Apuane
Massa, Tuscany, 54033, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
antonella vincenti
ospedale delle Apuane
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant
Study Record Dates
First Submitted
November 4, 2020
First Posted
November 10, 2020
Study Start
May 15, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
November 10, 2020
Record last verified: 2020-11