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

JRCT ID: jRCTs031200374

Registered date:24/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 25/02/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Patients will be randomized to either the recuperator plasma group or the standard treatment group, with the recuperator plasma group receiving plasma from those who have recovered from COVID-19.

Outcome(s)

• Primary Outcome: Time-weighted mean change in the amount of SARS-CoV-2 virus in nasopharyngeal swabs from day 0 to day 3 and day 5 of treatment

Secondary Outcome

Avoidance of ventilation or death
Death
Time to oxygen use
Assessment of time to clinical improvement
Clinical improvement in patients receiving convalescent plasma
Time to clinical improvement in convalescent plasma recipients
Time to improvement in the National Early Warning Score (NEWS) in the UK
Viral load in the convalescent plasma group at each assessment date
Safety endpoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Sho Saito
• Source(s) of Monetary Support: Health and Labor Sciences Research Grants,the National Center for Global Health and Medicine,Japan Agency for Medical Research and Development