Rationale Convalescent plasma (CCP) has been studied as a potential therapy for COVID-19, but data on its efficacy in Africa are limited. Objective In this trial we set out to determine the efficacy of CCP for treatment of COVID-19 in Uganda. Measurements Patients with a positive SARS-CoV-2 reverse transcriptase (RT)-PCR test irrespective of disease severity were hospitalised and randomised to receive either COVID-19 CCP plus standard of care (SOC) or SOC alone. The primary outcome was time to viral clearance, defined as having two consecutive RT-PCR-negative tests by day 28. Secondary outcomes included time to symptom resolution, clinical status on the modified WHO Ordinal Clinical Scale (≥1-point increase), progression to severe/critical condition (defined as oxygen saturation <93% or needing oxygen), mortality and safety. Main results A total of 136 patients were randomised, 69 to CCP+SOC and 67 to SOC only. The median age was 50 years (IQR: 38.5–62.0), 71.3% were male and the median duration of symptom was 7 days (IQR=4–8). Time to viral clearance was not different between the CCP+SOC and SOC arms (median of 6 days (IQR=4–11) vs 4 (IQR=4–6), p=0.196). There were no statistically significant differences in secondary outcomes in CCP+SOC versus SOC: time to symptom resolution (median=7 (IQR=5–7) vs 7 (IQR=5–10) days, p=0.450), disease progression (9 (22.0%) vs 7 (24.0%) patients, p=0.830) and mortality (10 (14.5%) vs 8 (11.9%) deaths, p=0.476). Conclusion In this African trial, CCP therapy did not result in beneficial virological or clinical improvements. Further trials are needed to determine subgroups of patients who may benefit from CCP in Africa. Trial registration number [NCT04542941][1]. Data are available upon reasonable request. Data collected for this trial, including de-identified individual participant data and a data dictionary defining each field in the set, will be made available to others upon reasonable request. Additional, related documents including study protocol, statistical analysis plan and informed consent forms will be made available upon reasonable request. A formal request should be sent via email to the clinical trial principal investigator Dr Bruce Kirenga at brucekirenga@yahoo.com. After approval of a proposal by an institutional research board with a signed data access agreement, data will be made available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04542941&atom=%2Fbmjresp%2F8%2F1%2Fe001017.atom

中文翻译：

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乌干达恢复期血浆治疗 COVID-19 的疗效

基本原理 恢复期血浆 (CCP) 已被研究作为 COVID-19 的潜在疗法，但其在非洲疗效的数据有限。目的 在本试验中，我们旨在确定 CCP 在乌干达治疗 COVID-19 的疗效。测量 SARS-CoV-2 逆转录酶 (RT)-PCR 检测呈阳性的患者，无论疾病严重程度如何，均被住院治疗并随机接受 COVID-19 CCP 加标准护理 (SOC) 或单独 SOC 治疗。主要结局是病毒清除时间，定义为在第 28 天进行两次连续 RT-PCR 阴性检测。次要结局包括症状消退时间、改良 WHO 普通临床量表的临床状态（增加≥1 分）、进展严重/危急情况（定义为氧饱和度 <93% 或需要氧气）、死亡率和安全性。主要结果 共有 136 名患者被随机分组​​，其中 69 名患者接受 CCP+SOC，67 名患者仅接受 SOC。中位年龄为 50 岁（IQR：38.5-62.0），71.3% 为男性，症状中位持续时间为 7 天（IQR=4-8）。CCP+SOC 组和 SOC 组之间的病毒清除时间没有差异（中位数为 6 天 (IQR=4–11) 与 4 天 (IQR=4–6)，p=0.196）。CCP+SOC 与 SOC 的次要结局没有统计学上的显着差异：症状缓解时间（中位数 = 7 (IQR=5–7) 与 7 (IQR=5–10) 天，p=0.450）、疾病进展（ 9 例 (22.0%) vs 7 例​​ (24.0%) 例患者，p=0.830）和死亡率（10 例 (14.5%) vs 8 例 (11.9%) 例死亡，p=0.476）。结论 在这项非洲试验中，CCP 疗法并未带来有益的病毒学或临床改善。需要进一步试验来确定可能从非洲 CCP 中受益的患者亚组。试用注册号[NCT04542941][1]。数据可根据合理要求提供。本次试验收集的数据，包括去识别化的个体参与者数据和定义该组中每个字段的数据字典，将根据合理请求向其他人提供。其他相关文件，包括研究方案、统计分析计划和知情同意书，将根据合理要求提供。正式请求应通过电子邮件发送给临床试验首席研究员 Bruce Kirenga 博士（brucekirenga@yahoo.com）。在机构研究委员会批准提案并签署数据访问协议后，将提供数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04542941&atom=%2Fbmjresp%2F8%2F1%2Fe001017.atom