An open-label, randomized, controlled trial to evaluate the efficacy of convalescent plasma therapy for COVID-19.

Phase 2

• Conditions: COVID-19; D000086382

• Registration Number: JPRN-jRCTs031200374
• Lead Sponsor: Sho Saito

Brief Summary

In patients with early-onset mild COVID-19 disease, the combination of convalescent plasma and standard therapies did not contribute to a decreased viral load within five days compared with that using standard therapy alone.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-24
• Study Completion: 2021-11-30
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

(1) Patients who have given written consent to participate in the study from themselves or their guardians.
(2) Hospitalized patients with a confirmed diagnosis of COVID-19 by PCR or LAMP, antigen testing, or other methods.
(3) Patients who meet all of the following requirements at the time of admission.
1)Within 5 days of onset
2) SpO2 of 95% or higher in room air
3) Aged 40 years or older or have one of the following underlying diseases
Renal dysfunction, chronic obstructive pulmonary disease (COPD), cardiac disease, cerebrovascular disease, malignancy, obesity, diabetes, hypertension, immunosuppressed state.
(4) 20 years of age or older at the time of obtaining consent.
(5) A person who is infected for the first time

Exclusion Criteria

(1)Those who are pregnant or breastfeeding
(2)Those whose religious beliefs do not support the administration of blood transfusions.
(3)Those who are participating in an interventional study that provides therapeutic intervention for COVID-19.
(4)Those who have been vaccinated against SARS-CoV-2.
(5)Patients who have already received convalescent plasma.
(6)Those with a history of allergy to blood products.
(7)Patients with plasma protein deficiency such as IgA
(8)Patients with NYHA class III or IV heart failure
(9)Others who are judged inappropriate for inclusion in the study by the principal investigator, principal investigator, or sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified