Background Elucidating the relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load and clinical outcomes is critical for understanding coronavirus disease 2019 (COVID-19). Methods The SARS-CoV-2 levels were analyzed by quantitative real-time polymerase chain reaction (RT-qPCR) of nasopharyngeal or oropharyngeal swab specimens collected at baseline, and clinical outcomes were recorded over 60 days from 1362 COVID-19 hospitalized patients enrolled in a multicenter, randomized, placebo-controlled phase 2/3 trial of sarilumab for COVID-19 (ClinicalTrials.gov NCT04315298). Results In post hoc analyses, higher baseline viral load, measured by both RT-qPCR cycle threshold and log10 copies/mL, was associated with greater supplemental oxygenation requirements and disease severity at study entry. Higher baseline viral load was associated with higher mortality, lower likelihood of improvement in clinical status and supplemental oxygenation requirements, and lower rates of hospital discharge. Viral load was not impacted by sarilumab treatment over time versus placebo. Conclusions These data support viral load as an important determinant of clinical outcomes in hospitalized patients with COVID-19 requiring supplemental oxygen or assisted ventilation.

中文翻译：

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基线严重急性呼吸综合征病毒载量与 2019 年冠状病毒病严重程度和临床结果相关：2/3 期试验的事后分析

背景 阐明严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 病毒载量与临床结果之间的关系对于了解 2019 年冠状病毒病 (COVID-19) 至关重要。方法 通过对基线时采集的鼻咽或口咽拭子标本进行定量实时聚合酶链反应 (RT-qPCR) 分析 SARS-CoV-2 水平，并记录 1362 名 COVID-19 住院患者 60 天内的临床结果sarilumab 用于 COVID-19 的多中心、随机、安慰剂对照 2/3 期试验（ClinicalTrials.gov NCT04315298）。结果 在事后分析中，通过 RT-qPCR 循环阈值和 log10 拷贝/mL 测量的较高基线病毒载量与研究开始时更高的补充氧合需求和疾病严重程度相关。较高的基线病毒载量与较高的死亡率、改善临床状况和补充氧合需求的可能性较低以及较低的出院率相关。与安慰剂相比，随着时间的推移，sarilumab 治疗不会影响病毒载量。结论 这些数据支持病毒载量是需要补充氧气或辅助通气的住院 COVID-19 患者临床结果的重要决定因素。