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.m3939
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发表时间：
2020-10-22
期刊：
影响因子：
--
通讯作者：
PLACID Trial Collaborators
中科院分区：
文献类型：
--
作者：
Agarwal A;Mukherjee A;Kumar G;Chatterjee P;Bhatnagar T;Malhotra P;PLACID Trial Collaborators
研究使用恢复期血浆治疗印度成人中度2019冠状病毒病（COVID-19）的有效性。开放标签、平行组、II期、多中心、随机对照试验。在印度有39家公立和私立医院。464名成人（≥18岁）入院（2020年4月22日至7月14日筛查），确诊中度新冠肺炎（动脉血氧分压/吸入氧分数（PaO 2/FiO 2）比值在200 mm Hg和300 mm Hg之间，或呼吸频率超过24/min，室内空气氧饱和度为93%或更低）：235名患者被分配至恢复期血浆治疗组，接受最佳标准治疗（干预组），229名患者仅接受最佳标准治疗（对照组）。干预组的参与者接受两次200 mL恢复期血浆，间隔24小时输注。未预先测定中和抗体的存在和水平;在研究结束时测定储存样品。入组后28天进展为重度疾病（PaO 2/FiO 2 <100 mm Hg）或全因死亡的复合终点。入组后28天，干预组44例（19%）受试者进展为重度疾病或全因死亡，对照组41例（18%）受试者进展为重度疾病或全因死亡（风险差0.008（95%置信区间-0.062至0.078）;风险比1.04，95%置信区间0.71至1.54）。恢复期血浆与进展为严重covid-19或全因死亡率的减少无关。该试验具有高度的普遍性，并且接近实验室容量有限的真实的生活环境中恢复期血浆的使用。先验测量供体和参与者的中和抗体滴度可能会进一步阐明恢复期血浆在新冠肺炎管理中的作用。印度临床试验注册中心CTRI/2020/04/024775。
To investigate the effectiveness of using convalescent plasma to treat moderate coronavirus disease 2019 (covid-19) in adults in India. Open label, parallel arm, phase II, multicentre, randomised controlled trial. 39 public and private hospitals across India. 464 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). Participants 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. Composite of progression to severe disease (PaO2/FiO2 <100 mm Hg) or all cause mortality at 28 days post-enrolment. Progression 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). Convalescent 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. Clinical Trial Registry of India CTRI/2020/04/024775.
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影响因子：
20.3
作者：
Hegerova, Livia;Gooley, Ted A.;Pagel, John M.
通讯作者：
Pagel, John M.
DOI：
10.1007/s10096-004-1271-9
发表时间：
2005-01
期刊：
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
影响因子：
--
作者：
Cheng Y;Wong R;Soo YO;Wong WS;Lee CK;Ng MH;Chan P;Wong KC;Leung CB;Cheng G
通讯作者：
Cheng G
影响因子：
120.7
作者：
Li, Ling;Zhang, Wei;Liu, Zhong
通讯作者：
Liu, Zhong
影响因子：
4.8
作者：
Norton, Edward C.;Miller, Morgen M.;Kleinman, Lawrence C.
通讯作者：
Kleinman, Lawrence C.
DOI：
10.1056/nejmoa1511812
发表时间：
2016-01-07
期刊：
The New England journal of medicine
影响因子：
--
作者：
van Griensven J;Edwards T;de Lamballerie X;Semple MG;Gallian P;Baize S;Horby PW;Raoul H;Magassouba N;Antierens A;Lomas C;Faye O;Sall AA;Fransen K;Buyze J;Ravinetto R;Tiberghien P;Claeys Y;De Crop M;Lynen L;Bah EI;Smith PG;Delamou A;De Weggheleire A;Haba N;Ebola-Tx Consortium
通讯作者：
Ebola-Tx Consortium