Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.
Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.
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DOI：
10.1056/nejmoa2022926
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发表时间：
2020-11-19
期刊：
影响因子：
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通讯作者：
Landray MJ
中科院分区：
文献类型：
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作者：
RECOVERY Collaborative Group;Horby P;Mafham M;Linsell L;Bell JL;Staplin N;Emberson JR;Wiselka M;Ustianowski A;Elmahi E;Prudon B;Whitehouse T;Felton T;Williams J;Faccenda J;Underwood J;Baillie JK;Chappell LC;Faust SN;Jaki T;Jeffery K;Lim WS;Montgomery A;Rowan K;Tarning J;Watson JA;White NJ;Juszczak E;Haynes R;Landray MJ
根据体外活性、非对照数据和小型随机研究，羟氯喹和氯喹已被提议作为2019冠状病毒病（COVID-19）的治疗药物。COVID-19治疗的随机评价（RECOVERY）试验是一项随机、对照、开放标签、平台试验，比较了COVID-19住院患者的一系列可能治疗与常规护理。我们报告的初步结果比较羟氯喹与常规护理。主要结局为28天死亡率。1561例随机分配接受羟氯喹治疗的患者与3155例同时分配接受常规治疗的患者进行比较。总体而言，421例（27.0%）接受羟氯喹治疗的患者和790例（25.0%）接受常规治疗的患者在28天内死亡（率比1.09; 95%置信区间[CI] 0.97 - 1.23; P=0.15）。在所有预先指定的患者亚组中观察到一致的结果。结果表明，分配给羟氯喹的患者可能不太可能在28天内活着出院（59.9%对63.0%;率比0.90; 95%CI 0.84-0.98），并且基线时未接受有创机械通气的患者可能更有可能达到有创机械通气或死亡的复合终点（30.2% vs. 26.8%;风险比1.13; 95% CI 1.02-1.25）。未发生过多新发严重心律失常。在因COVID-19住院的患者中，羟氯喹与28天死亡率的降低无关，但与住院时间的延长和进展为有创机械通气或死亡的风险增加有关。医学研究理事会和NIHR（授权参考号：MC_PC_19056）。该试验已在ISRCTN（50189673）和clinicaltrials.gov（NCT 04381936）注册。
Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (COVID-19) on the basis of in vitro activity, uncontrolled data, and small randomized studies. The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized, controlled, open-label, platform trial comparing a range of possible treatments with usual care in patients hospitalized with COVID-19. We report the preliminary results for the comparison of hydroxychloroquine vs. usual care alone. The primary outcome was 28-day mortality. 1561 patients randomly allocated to receive hydroxychloroquine were compared with 3155 patients concurrently allocated to usual care. Overall, 421 (27.0%) patients allocated hydroxychloroquine and 790 (25.0%) patients allocated usual care died within 28 days (rate ratio 1.09; 95% confidence interval [CI] 0.97 to 1.23; P=0.15). Consistent results were seen in all pre-specified subgroups of patients. The results suggest that patients allocated to hydroxychloroquine may be less likely to be discharged from hospital alive within 28 days (59.9% vs. 63.0%; rate ratio 0.90; 95% CI 0.84-0.98) and that those not on invasive mechanical ventilation at baseline may be more likely to reach the composite endpoint of invasive mechanical ventilation or death (30.2% vs. 26.8%; risk ratio 1.13; 95% CI 1.02-1.25). There was no excess of new major cardiac arrhythmia. In patients hospitalized with COVID-19, hydroxychloroquine was not associated with reductions in 28-day mortality but was associated with an increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation or death. Medical Research Council and NIHR (Grant ref: MC_PC_19056). The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936).