COVID-19 COVID-19
Conditions
Interventions
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.
COVID-19 serotherapy, COVID-19 convalescent plasma treatment
Sponsors
Sho Saito
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHidetoshi Nomoto
Centor Hospital of the National Center for Global Health and Medicine
Outcome results
None listed