COVIPLA-R

Not Applicable

• Conditions: COVID-19, Coronavirus disease; COVID-19, coronavirus disease, SARS-CoV-2, 2019-nCoV; C000657245

• Registration Number: JPRN-jRCTs031200124
• Lead Sponsor: Saito Sho

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Study Completion: 2021-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
se of ventilator or death at 14 days post-administration

Secondary Outcome Measures

Name	Time	Method
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