Japanease

Sept. 17, 2020

Dec. 08, 2020

jRCTs031200124

Study on the use of Convalescent plasma therapy as a COVID-19 treatment (Study on the use of Convalescent plasma therapy as a COVID-19 treatment)

COVIPLA-R (COVIPLA-R)

Kutsuna Satoshi

National Center for Global Health and Medicine

1-21-1, Toyama, Shinjuku-ku, Tokyo

+81-3-3202-7181

skutsuna@hosp.ncgm.go.jp

Saito Sho

National Center for Global Health and Medicine, Disease control and prevention center

1-21-1, Toyama, Shinjuku-ku, Tokyo

+81-3-3202-7181

ssaito@hosp.ncgm.go.jp

Oct. 01, 2020

59

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

none

1) Written consent obtained from the patient or his/her legal representative.
2) COVID-19 diagnosed by PCR, LAMP, etc. and was admitted.
3) Patients who satisfy the following at admission: A) SpO2 <= 94% or B) require supplimental oxygen.
4) 20 years or older at enrollment

1) Pregnant or breastfeeding at enrollment
2) Unable to conduct blood transfusion due to religious reasons
3) Enrolled in other COVID-19 intervension study
4) Previously administered with COVID-19 convalescent plasma
5) Known allergy to blood products
6) Deficiency of plasma protein, such as IgA
7) Not appropriate to enroll determined by the PI for other reasons

20age old over
No limit

Both

COVID-19, Coronavirus disease

C000705128

COVID-19 convalescent plasma therapy, Immunoglobulin therapy

Administration of COVID-19 convalescent plasma 200 mL collected from patients recovered from COVID-19

C000657245

COVID-19, coronavirus disease, SARS-CoV-2, 2019-nCoV

Use of ventilator or death at 14 days post-administration

SARS-CoV-2 virus copy tested in nasopharynx swab at 14 days post administration, clinical recovery at 14 days post administration, chronological change in blood test results, adverse reaction occurence after administration

Recruiting

Ministry of Health, Labour, and Welfare; In house fund; and Japan Agency for Medical Research and Development
Not applicable
Institutional Review Board for Clinical Research of National Center for Global Health and Medicine
1-21-1 Toyama, Shinjuku-ku, Tokyo, Tokyo

+81-3-3202-7181

rinrijm@hosp.ncgm.go.jp
Approval

Sept. 15, 2020