Assessment of Safety and Efficacy of COVID-19 Convalescent Plasma for Treatment of COVID-19 in Adults in Uganda; A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Time to viral clearance (RT-PCR negativity)
研究概览
简要总结
Currently there are no proven treatments or vaccines for COVID-19 and care of the COVID patients is largely supportive involving treatment of symptoms such as fever with antipyretics, secondary bacterial chest infection with antibiotics and meticulous management of comorbid conditions.
Several repurposed and new drugs have been investigated for treatment of COVID-19, however, none have been confirmed to be efficacious. These drugs include the antimalarials (chloroquine and hydroxychloroquine), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such lopinavir/ritonavir.
There is emerging evidence to support the use of COVID convalescent plasma for the treatment of COVID-19. There is need to leverage the blood transfusion services in countries and this is beginning to happen on the continent.
详细描述
Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. While treatments are being investigated in the Western world, it is likely that these data will take several months to become available and if proven to be efficacious, access in most of the low-income countries will be limited due to the high global demand and exorbitant costs.
In this study, the investigators aim to assess the safety and efficacy of use of CCP for treatment of adults with COVID-19 in Uganda.
The investigators hypothesise that administration of CCP to patients with positive SARS-CoV-2 RT PCR leads to earlier time to viral clearance compared to the standard of care.
Objectives:
General objective The overall objective of this project is to assess the safety and efficacy of COVID-19 convalescent plasma in the treatment of COVID-19 in Uganda.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with documented laboratory RT PCR confirmed SAR-CoV-2 infection
- •Patients able to provide informed consent. In the event that the patient cannot provide consent e.g. they are severely sick, the next of kin or legal surrogate decision make
排除标准
- •Prior diagnosis of IgA deficiency
- •Inability to return for post discharge follow up
结局指标
主要结局
Time to viral clearance (RT-PCR negativity)
时间窗: 28 days
The primary end point will be time to viral clearance (RT-PCR negativity).
次要结局
- Time to symptom resolution(28 days)
- Time to severe/critical disease(28 days)
- Number of participants reporting an adverse event as evidenced by clinical manifestations(28 days)