Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).
Convalescent plasma in the management of moderate covid-19 in adults in India: open label phase II multicentre randomised controlled trial (PLACID Trial).
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DOI：
10.1136/bmj.m4232
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发表时间：
2020-11-03
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目的探讨恢复期血浆治疗印度成人中度冠状病毒病2019年(新冠肺炎)的疗效。随机对照试验。印度39家公立和私立医院。464名成年人(≥18岁)入院(2020年4月22日至7月14日进行筛查)，确诊为中度新冠肺炎(动脉血氧分压/吸入氧分数(PaO2/FiO2)介于200 mm Hg至300 mm Hg之间，或呼吸频率大于24次/分钟，室内空气中氧饱和度低于93%)：235人被分配到最佳护理标准的恢复期血浆组(干预组)，229人分配给最佳护理标准的单纯疗养组(对照组)。干预组的参与者接受两剂200毫升的康复期血浆，相隔24小时输血。中和抗体的存在和水平没有事先测量；储存的样本在研究结束时被检测。主要结果测量在登记后28天进展到严重疾病(PaO2/FiO2和lt；100 mm Hg)或所有原因死亡的综合情况。结果在登记后28天，干预组44人(19%)和对照组41人(18%)进展到严重疾病或所有原因死亡(风险差异0.008(95%可信区间−0.062至0.078)；风险比1.04，95%可信区间0.71至1.54)。结论恢复期血浆与进展为重度新冠肺炎或全因死亡率无关。这项试验具有很高的通用性，接近于在实验室能力有限的真实生活环境中使用恢复期血浆。对捐赠者和参与者中和抗体滴度的先验测量可能会进一步阐明恢复期血浆在Covid-19管理中的作用。
ObjectiveTo investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India.DesignOpen label, parallel arm, phase II, multicentre, randomised controlled trial.Setting39 public and private hospitals across India.Participants464 adults (≥18 years) admitted to hospital (screened 22 April to 14 July 2020) with confirmed moderate covid-19 (partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio between 200 mm Hg and 300 mm Hg or a respiratory rate of more than 24/min with oxygen saturation 93% or less on room air): 235 were assigned to convalescent plasma with best standard of care (intervention arm) and 229 to best standard of care only (control arm).InterventionsParticipants in the intervention arm received two doses of 200 mL convalescent plasma, transfused 24 hours apart. The presence and levels of neutralising antibodies were not measured a priori; stored samples were assayed at the end of the study.Main outcome measureComposite of progression to severe disease (PaO2/FiO2<100 mm Hg) or all cause mortality at 28 days post-enrolment.ResultsProgression to severe disease or all cause mortality at 28 days after enrolment occurred in 44 (19%) participants in the intervention arm and 41 (18%) in the control arm (risk difference 0.008 (95% confidence interval −0.062 to 0.078); risk ratio 1.04, 95% confidence interval 0.71 to 1.54).ConclusionConvalescent plasma was not associated with a reduction in progression to severe covid-19 or all cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity. A priori measurement of neutralising antibody titres in donors and participants might further clarify the role of convalescent plasma in the management of covid-19.Trial registrationClinical Trial Registry of India CTRI/2020/04/024775.