JPRN-jRCTs031200374
Completed
Phase 2
An open-label, randomized, controlled trial to evaluate the efficacy of convalescent plasma therapy for COVID-19. - COVIPLA-RCT
Sho Saito0 sites25 target enrollmentFebruary 24, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Sho Saito
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility 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
- •(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.
Outcomes
Primary Outcomes
Not specified
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