Early Use of Hyperimmune Plasma in COVID-19 | NCT04721236

Studies
Early Use of Hyperimmune Plasma in COVID-19

NCT04721236

Sponsor

Catherine Klersy

Status

Unknown status

Last Update Posted

Mar 31, 2022Actual

Enrollment

260Actual

Phase

Not Applicable

Conditions

Covid19

Interventions

hyperimmune 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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2020Actual

Primary Completion Date

May 19, 2021Actual

Completion Date

May 19, 2022Estimated

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 21, 2021

First Posted Date

Jan 22, 2021Actual

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

Mar 30, 2022

Last Update Posted Date

Mar 31, 2022Actual

Name	Class
Fondazione IRCCS Policlinico San Matteo di Pavia	OTHER

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale

Detailed Description

Patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . Plasma titration will depend on the availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single	Experimental	hyperimmune plasma with titre 1:80 or more	Other: hyperimmune plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyperimmune plasma	Other	plasma collected from convalescent Covid-19 donors with titre 1:80 or more	Single

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical improvement (efficacy)	Clinical improvement is obtained when a patient decreases his/her score by 2 points on the ten-category ordinal WHO scale or is discharged alive from the hospital, whichever comes first. The WHO scale is chosen in accordance with the "Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme" recently published in Lancet Infectious Diseases (WHO, 2020).	28 days

Secondary Outcomes

Measure	Description	Time Frame
ventilation	Ventilator-free days	Days: from 0 to 7, 14 and 28
WHO (World Health Organization) scale	WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
Male or female adult patient ≥18 years of age at time of enrolment.
Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
The patient is not eligible in the Tsunami trial.

Exclusion Criteria:

Participation in any other clinical trial of an experimental treatment for COVID-19.
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
Pregnancy
Current documented and uncontrolled bacterial infection.

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

Name	Affiliation	Role
Francesco Mojoli, MD	Fondazione IRCCS Policlinico San Matteo	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Catherine Klersy		Pavia		27100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

may be available upon motivated requesto to PI

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

ID	Term
D019264	Adoptive Transfer
D007116	Immunization, Passive
D007114	Immunization
D007167	Immunotherapy