Importance Hydroxychloroquine, with or without azithromycin, has been considered as a possible therapeutic agent for patients with coronavirus disease 2019 (COVID-19). However, there are limited data on efficacy and associated adverse events. Objective To describe the association between use of hydroxychloroquine, with or without azithromycin, and clinical outcomes among hospital inpatients diagnosed with COVID-19. Design, Setting, and Participants Retrospective multicenter cohort study of patients from a random sample of all admitted patients with laboratory-confirmed COVID-19 in 25 hospitals, representing 88.2% of patients with COVID-19 in the New York metropolitan region. Eligible patients were admitted for at least 24 hours between March 15 and 28, 2020. Medications, preexisting conditions, clinical measures on admission, outcomes, and adverse events were abstracted from medical records. The date of final follow-up was April 24, 2020. Exposures Receipt of both hydroxychloroquine and azithromycin, hydroxychloroquine alone, azithromycin alone, or neither. Main Outcomes and Measures Primary outcome was in-hospital mortality. Secondary outcomes were cardiac arrest and abnormal electrocardiogram findings (arrhythmia or QT prolongation). Results Among 1438 hospitalized patients with a diagnosis of COVID-19 (858 [59.7%] male, median age, 63 years), those receiving hydroxychloroquine, azithromycin, or both were more likely than those not receiving either drug to have diabetes, respiratory rate >22/min, abnormal chest imaging findings, O2 saturation lower than 90%, and aspartate aminotransferase greater than 40 U/L. Overall in-hospital mortality was 20.3% (95% CI, 18.2%-22.4%). The probability of death for patients receiving hydroxychloroquine + azithromycin was 189/735 (25.7% [95% CI, 22.3%-28.9%]), hydroxychloroquine alone, 54/271 (19.9% [95% CI, 15.2%-24.7%]), azithromycin alone, 21/211 (10.0% [95% CI, 5.9%-14.0%]), and neither drug, 28/221 (12.7% [95% CI, 8.3%-17.1%]). In adjusted Cox proportional hazards models, compared with patients receiving neither drug, there were no significant differences in mortality for patients receiving hydroxychloroquine + azithromycin (HR, 1.35 [95% CI, 0.76-2.40]), hydroxychloroquine alone (HR, 1.08 [95% CI, 0.63-1.85]), or azithromycin alone (HR, 0.56 [95% CI, 0.26-1.21]). In logistic models, compared with patients receiving neither drug cardiac arrest was significantly more likely in patients receiving hydroxychloroquine + azithromycin (adjusted OR, 2.13 [95% CI, 1.12-4.05]), but not hydroxychloroquine alone (adjusted OR, 1.91 [95% CI, 0.96-3.81]) or azithromycin alone (adjusted OR, 0.64 [95% CI, 0.27-1.56]), . In adjusted logistic regression models, there were no significant differences in the relative likelihood of abnormal electrocardiogram findings. Conclusions and Relevance Among patients hospitalized in metropolitan New York with COVID-19, treatment with hydroxychloroquine, azithromycin, or both, compared with neither treatment, was not significantly associated with differences in in-hospital mortality. However, the interpretation of these findings may be limited by the observational design.

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羟氯喹或阿奇霉素治疗与纽约州 COVID-19 患者院内死亡率的关系

重要性 羟氯喹（无论是否联合阿奇霉素）已被认为是 2019 年冠状病毒病 (COVID-19) 患者的可能治疗药物。然而，关于疗效和相关不良事件的数据有限。目的 描述使用羟氯喹（联合或不联合阿奇霉素）与诊断为 COVID-19 的住院患者临床结果之间的关联。设计、设置和参与者 回顾性多中心队列研究，对 25 家医院所有入院的经实验室确诊的 COVID-19 患者进行随机抽样，占纽约大都市区 COVID-19 患者的 88.2%。符合条件的患者在 2020 年 3 月 15 日至 28 日期间入院至少 24 小时。从医疗记录中提取药物、既往病史、入院时的临床措施、结果和不良事件。最终随访日期为 2020 年 4 月 24 日。 暴露 接受羟氯喹和阿奇霉素、单独服用羟氯喹、单独服用阿奇霉素，或两者均未服用。主要结果和措施 主要结果是院内死亡率。次要结局是心脏骤停和心电图异常（心律失常或 QT 间期延长）。结果 在 1438 名诊断为 COVID-19 的住院患者中（858 名 [59.7%] 男性，中位年龄 63 岁），接受羟氯喹、阿奇霉素或两者药物治疗的患者比未接受任一药物的患者更有可能患有糖尿病、呼吸频率>22/min，胸部影像学异常，O2 饱和度低于 90%，天冬氨酸转氨酶大于 40 U/L。总体院内死亡率为 20.3%（95% CI，18.2%-22.4%）。接受羟氯喹+阿奇霉素治疗的患者死亡概率为 189/735 (25.7% [95% CI, 22.3%-28.9%])，单用羟氯喹为 54/271 (19.9% [95% CI, 15.2%-24.7%]) ），单用阿奇霉素，21/211（10.0% [95% CI, 5.9%-14.0%]），两种药物都不使用，28/221（12.7% [95% CI, 8.3%-17.1%]）。在调整后的 Cox 比例风险模型中，与未接受任何药物治疗的患者相比，接受羟氯喹 + 阿奇霉素治疗的患者（HR，1.35 [95% CI，0.76-2.40]）、单独接受羟氯喹治疗的患者（HR，1.08 [95]）死亡率没有显着差异。 % CI，0.63-1.85]），或单独使用阿奇霉素（HR，0.56 [95% CI，0.26-1.21]）。在逻辑模型中，与未接受任何药物治疗的患者相比，接受羟氯喹+阿奇霉素治疗的患者心脏骤停的可能性显着更高（调整后的 OR，2.13 [95% CI，1.12-4.05]），但单独使用羟氯喹的患者则不然（调整后的 OR，1.91 [95% CI，1.12-4.05]） CI，0.96-3.81]）或单独使用阿奇霉素（调整后的 OR，0.64 [95% CI，0.27-1.56]），. 在调整后的逻辑回归模型中，心电图异常结果的相对可能性没有显着差异。结论和相关性 在纽约大都会住院接受羟氯喹、阿奇霉素或两者治疗的 COVID-19 患者中，与这两种治疗相比，与院内死亡率的差异没有显着相关性。然而，这些发现的解释可能受到观察设计的限制。