COVID-CP Banking

JRCT ID: jRCT1030200279

Registered date:25/12/2020

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: coronavirus disease 2019
• Date of first enrollment: 25/12/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Plasma of a person who has recovered from infection and who is negative for the new coronavirus (SARS-CoV-2) and has a high neutralizing antibody titer should be collected using a component blood sampling device for blood sampling of both arms.

Planned plasma collection amount
(Male) 45 kg to less than 50 kg and (Woman) 40 kg to less than 50 kg: 340 ml (240 ml + research 80 ml + dead space 20 ml)
more than 50kg: 580ml (240mlx2 back + 80ml for research + 20ml dead space)

Outcome(s)

• Primary Outcome: Safety of COVID-19 CP donor
• Secondary Outcome: Feasibility of COVID-19 CP Banking

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 69age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Tanosaki Ryuji
• Secondary Sponsor: Saya Hideyuki
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare