plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-1... | NCT04622826

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

NCT04622826

Sponsor

Azienda USL Toscana Nord Ovest

Status

Unknown status

Last Update Posted

Nov 10, 2020Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Covid-19 Pneumonia

Interventions

immune plasma

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Nov 4, 2020

First Submission Date that Met QC Criteria

Nov 7, 2020

First Posted Date

Nov 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sequential immune plasma infused patients	Experimental	immune covid 19 plasma infusion	Biological: immune plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
immune plasma	Biological	immune covid 19 plasma infusion	sequential immune plasma infused patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mirko lombardi	Contact	00393478546332		mirkolombardi9@gmail.com
antonella vincenti	Contact	003905854931		antonella.vincenti@uslnordovest.toscana.it

Overall Officials

Name	Affiliation	Role
antonella vincenti	ospedale delle Apuane	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale delle Apuane	Recruiting	Massa	Tuscany	54033	Italy