臨床研究等提出・公開システム

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)

11

Of the 11 subjects, 8 were male and 3 were female. The minimum age at onset was 39 and the maximum was 90. Patients were enrolled if they met one of the following criteria at admission: (1) SpO2 less than 94% or (2) required oxygen administration.

Enrollment period: September 17, 2020~December 31, 2022 Observation period: September 17, 2020~March 31, 2023 Discontinuation decided on: December 9, 2021 This study was terminated in the middle of the planned study period. Therefore, the observation period ended when the last subject enrolled completed the last visit.

Of the AEs occurred, only "redness/pruritus" at the injection site was considered causal. There was one case of death aas a SAE. Other adverse events included elevated AST and ALT, and steroid diabetes. The study drug (convalescent plasma) was generally well tolerated in patients with moderate or severe COVID-19.

Of the 11 subjects enrolled, none died within 14-days period from the first day of treatment. During the same period, no subject required invasive respiratory management. The mean SARS-CoV-2 viral load before treatment was 67914 (SD 210822), and at day 14 the mean was 3195 (SD 10595). The mean difference was -64719 (standard deviation 63877) with 95% confidence interval (-207045, 77607), indicating a decreasing trend. Xu (JAMA, 2020) and a report by the Japanese Association for Infectious Diseases reported that 25% of patients with nonmild disease required invasive respiratory management (intubation), but the rate of intubation in this study was lower, thereby it is expected that the study drug is effective at a certain level. However, due to the limited data, it did not clearly demonstrate the efficacy.

The study was terminated; the analysis originally planned was not performed. The study was terminated in accordance with the recommendation of the Efficacy and Safety Evaluation Committee. However, this does not negate the assumption: "The rate of intubation in the existing treatment is assumed to be 25%, and this rate should be reduced by more than half (i.e., to 12% or less).

May. 31, 2022

No

None

https://jrct.niph.go.jp/latest-detail/jRCTs031200124

Saito Sho

National Center for Global Health and Medicine

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

ssaito@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

Complete

Sept. 17, 2020

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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

Both

COVID-19, Coronavirus disease

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

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

COVID-19 convalescent plasma therapy, Immunoglobulin therapy

C000657245

C000705128

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

+81-3-3202-7181

none