MedPath

COVID-CP Banking

Not Applicable
Suspended
Conditions
D000086382
coronavirus disease 2019
COVID19 Plasma therapy Biobank Biobanking
Registration Number
JPRN-jRCT1030200279
Lead Sponsor
Tanosaki Ryuji
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
All
Target Recruitment
100
Inclusion Criteria

(1) Blood type (ABO, Rh type) and irregular antibody are negative (Keio University Hospital)
(2) The following infectious disease screening antigen antibody test is negative or within the blood donation standard range: syphilis serological test, hepatitis B virus test (HBs antigen, HBs antibody, HBc antibody), hepatitis C virus test (HCV antibody) ), HIV test (HIV-1, 2 antibody), HTLV-1 antibody test, human parvovirus test, nucleic acid amplification test (HBV, HCV, HIV) (when antibody test of each virus becomes positive) (consigned to Nisseki And carry out)
(3) SARS-CoV-2 neutralizing antibody titer (conducted at National Institute of Infectious Diseases Toyama Government Building) is high titer positive (1: 160 or more is a guide).
(4) SARS-CoV-2 blood PCR (conducted at the National Institute of Infectious Diseases Murayama Government Building) is negative.

Exclusion Criteria

1) A clinically meaningful irregular antibody becomes positive,
2) The infectious disease screening is positive or out of the blood donation standard range.
3) SARS-CoV-2 neutralizing antibody titer was judged to be low (1:80 or less is a guideline. Since the criteria are not sufficiently standardized, it will be decided in consultation with the National Institute of Infectious Diseases)
4) SARS-CoV-2 PCR is positive
5) The person in charge of business determines that it is inappropriate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety of COVID-19 CP donor
Secondary Outcome Measures
NameTimeMethod
Feasibility of COVID-19 CP Banking
© Copyright 2025. All Rights Reserved by MedPath