Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.
Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial.
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DOI：
10.1016/s0140-6736(21)00897-7
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发表时间：
2021-05-29
期刊：
影响因子：
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通讯作者：
RECOVERY Collaborative Group
中科院分区：
文献类型：
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作者：
RECOVERY Collaborative Group
许多COVID-19患者接受了含有抗SARS-CoV-2抗体的血浆治疗。我们的目的是评估恢复期血浆治疗在因COVID-19入院的患者中的安全性和有效性。这项随机、对照、开放标签、平台试验（COVID-19治疗的随机评价[RECOVERY]）正在评估英国因COVID-19住院患者的几种可能治疗方法。该试验正在英国177家NHS医院进行。符合条件并同意的患者被随机分配（1：1）接受单独的常规护理（常规护理组）或常规护理加高滴度恢复期血浆（恢复期血浆组）。主要结局是28天死亡率，在意向治疗的基础上进行分析。该试验已在ISRCTN（50189673）和ClinicalTrials.gov（NCT 04381936）注册。在2020年5月28日至2021年1月15日期间，16287例入选RECOVERY的患者中有11558例（71%）有资格接受恢复期血浆，并被分配到恢复期血浆组或常规护理组。两组之间的28天死亡率无显著差异：恢复期血浆组5795例患者中有1399例（24%）在28天内死亡，常规护理组5763例患者中有1408例（24%）在28天内死亡（率比1.00，95%CI 0.93 - 1.07; p= 0.95）。所有预先指定的患者亚组的28天死亡率比值相似，包括随机分组时未检测到SARS-CoV-2抗体的患者。恢复期血浆分配对28天内出院的患者比例无显著影响（恢复期血浆组3832例[66%]患者vs常规治疗组3822例[66%]患者;率比0.99，95%CI 0.94 - 1.03; p= 0.57）。在随机化时未接受有创机械通气的患者中，达到进展为有创机械通气或死亡复合终点的患者比例没有显着差异（恢复期血浆组5493例患者中的1568例[29%] vs常规护理组5448例患者中的1568例[29%];率比0.99，95%CI 0.93 - 1.05; p= 0.79）。在因COVID-19住院的患者中，高滴度恢复期血浆并没有改善生存率或其他预先规定的临床结局。英国研究和创新（医学研究理事会）和国家健康研究所。
Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. UK Research and Innovation (Medical Research Council) and National Institute of Health Research.