JPRN-jRCTs031200374已完成2 期
An open-label, randomized, controlled trial to evaluate the efficacy of convalescent plasma therapy for COVID-19. - COVIPLA-RCT
Sho Saito0 个研究点目标入组 25 人开始时间: 2021年2月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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.
研究者
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