在疾病管理和能力方面，COVID-19在癌症患者中的严重程度和死亡率是否有所改善尚有待确定。本研究探讨COVID-19在大流行期间癌症患者的严重程度和死亡率是否有所改善。

OnCovid是欧洲的一个登记处，用于收集连续的实体肿瘤或血液肿瘤患者和COVID-19的数据。这个多中心案例系列研究包括来自6个国家(英国、意大利、西班牙、法国、比利时和德国)的35个机构的真实世界数据。这次更新包括在2020年2月27日至2021年2月14日期间确诊的患者。纳入标准为确诊SARS-CoV-2感染，有实体癌或血液肿瘤史。

主要结果和措施：在14天和3个月时将死亡区分为两个终点。通过对5个阶段(2020年2月至3月、2020年4月至6月、2020年7月至9月、2020年10月至12月和2021年1月至2月)和2次重大疫情(2020年2月至6月和2020年7月至2021年2月)的患者进行分层，比较了患者的特征和结果。

数据截止时，共纳入2795例连续患者，其中2634例符合分析条件(中位[IQR]年龄68[18-77]岁;52.8%的男性)。符合条件的患者在14天病死率(CFR)方面表现出显著的时间依赖性改善，2020年2月至3月的估计病死率为29.8% (95% CI, 0.26-0.33);2020年4月至6月20.3%(95%可信区间，0.17-0.23);2020年7月至9月:12.5% (95% CI, 0.06-22.90);2020年10月至12月17.2% (95% CI, 0.15-0.21);和14.5% (95% CI, 0.09-0.21)的2021年1月至2月(所有P < .001)的预定义阶段。

与第二次大暴发相比，第一次大暴发确诊的患者65岁或以上的可能性更大(1626人中有974人[60.3%]，1008人中有564人[56.1%];P = .03)，至少有2例共患(793 / 1626 [48.8%]vs 427 / 1008 [42.4%];P = .001)，肿瘤晚期(1626例中有708例[46.4%]，1008例中有536例[56.1%];P <.001)。COVID-19并发症的发生率更高(1626例中738例[45.4%]，1008例中342例[33.9%];P < .001)，需要住院治疗(1626人中969人[59.8%]，1008人中418人[42.1%];P < .001)和抗新冠治疗(1004 / 1626 [61.7%]vs 501 / 1008 [49.7%];P < .001)在第一次大爆发期间。第一次和第二次主要暴发的14天CFRs分别为25.6% (95% CI, 0.23-0.28)和16.2% (95% CI, 0.13-0.19;P < .001)，分别。在调整国家、性别、年龄、共病、肿瘤分期和状态、抗COVID-19和抗癌治疗以及COVID-19并发症后，首次暴发时确诊的患者在14天内死亡的风险增加(危险比[HR]， 1.85;95% CI, 1.47-2.32)和3个月(HR, 1.28;95% CI, 1.08-1.51))。

这项基于登记的研究结果表明，在欧洲，诊断为COVID-19的癌症患者的死亡率有所改善;这种改善可能与早期诊断、改进管理和社区传播随时间的动态变化有关。

Importance  

Whether the severity and mortality of COVID-19 in patients with cancer have improved in terms of disease management and capacity is yet to be defined.

Objective  

To test whether severity and mortality from COVID-19 among patients with cancer have improved during the course of the pandemic.

Design, Setting, and Participants  

OnCovid is a European registry that collects data on consecutive patients with solid or hematologic cancer and COVID-19. This multicenter case series study included real-world data from 35 institutions across 6 countries (UK, Italy, Spain, France, Belgium, and Germany). This update included patients diagnosed between February 27, 2020, and February, 14, 2021. Inclusion criteria were confirmed diagnosis of SARS-CoV-2 infection and a history of solid or hematologic cancer.

Exposures  

SARS-CoV-2 infection.

Main Outcomes and Measures  

Deaths were differentiated at 14 days and 3 months as the 2 landmark end points. Patient characteristics and outcomes were compared by stratifying patients across 5 phases (February to March 2020, April to June 2020, July to September 2020, October to December 2020, and January to February 2021) and across 2 major outbreaks (February to June 2020 and July 2020 to February 2021).

Results  

At data cutoff, 2795 consecutive patients were included, with 2634 patients eligible for analysis (median [IQR] age, 68 [18-77] years ; 52.8% men). Eligible patients demonstrated significant time-dependent improvement in 14-day case-fatality rate (CFR) with estimates of 29.8% (95% CI, 0.26-0.33) for February to March 2020; 20.3% (95% CI, 0.17-0.23) for April to June 2020; 12.5% (95% CI, 0.06-22.90) for July to September 2020; 17.2% (95% CI, 0.15-0.21) for October to December 2020; and 14.5% (95% CI, 0.09-0.21) for January to February 2021 (all P < .001) across the predefined phases. Compared with the second major outbreak, patients diagnosed in the first outbreak were more likely to be 65 years or older (974 of 1626 [60.3%] vs 564 of 1008 [56.1%]; P = .03), have at least 2 comorbidities (793 of 1626 [48.8%] vs 427 of 1008 [42.4%]; P = .001), and have advanced tumors (708 of 1626 [46.4%] vs 536 of 1008 [56.1%]; P < .001). Complications of COVID-19 were more likely to be seen (738 of 1626 [45.4%] vs 342 of 1008 [33.9%]; P < .001) and require hospitalization (969 of 1626 [59.8%] vs 418 of 1008 [42.1%]; P < .001) and anti–COVID-19 therapy (1004 of 1626 [61.7%] vs 501 of 1008 [49.7%]; P < .001) during the first major outbreak. The 14-day CFRs for the first and second major outbreaks were 25.6% (95% CI, 0.23-0.28) vs 16.2% (95% CI, 0.13-0.19; P < .001), respectively. After adjusting for country, sex, age, comorbidities, tumor stage and status, anti–COVID-19 and anticancer therapy, and COVID-19 complications, patients diagnosed in the first outbreak had an increased risk of death at 14 days (hazard ratio [HR], 1.85; 95% CI, 1.47-2.32) and 3 months (HR, 1.28; 95% CI, 1.08-1.51) compared with those diagnosed in the second outbreak.

Conclusions and Relevance  

The findings of this registry-based study suggest that mortality in patients with cancer diagnosed with COVID-19 has improved in Europe; this improvement may be associated with earlier diagnosis, improved management, and dynamic changes in community transmission over time.

2020年初，为了防止SARS-CoV-2的传播，禁止了大规模室内集会。近期发表在《柳叶刀·传染病学》杂志上的研究评估在受控条件下，在大型室内聚会活动中，考虑到实施包括3天内抗原筛查、佩戴医用口罩和优化通风等综合预防策略，参与者中的感染率是否与非参与者中的感染率相似。

方法：

这项非劣效性、前瞻性、开放、随机、对照的SPRING试验于2021年5月29日在法国巴黎的雅高竞技场举行的现场室内音乐会中对参与者进行。参与者年龄18-45岁，通过专门的网站招募，无共病、COVID-19症状或近期病例接触，在音乐会前3天内快速抗原诊断检测呈阴性。参与者按2:1的比例随机分配到实验组(参与者)和对照组(非参与者)。分配序列由计算机生成，通过排列大小为3、6或9的块，没有分层。主要结果衡量指标是按方案人群收集后7天自取唾液RT-PCR检测新冠阳性的患者数量(非劣效性差值< 0.35%)。

结果：

2021年5月11日至25日，在该网站上注册的18845人，随机选择10953人进行登记前现场访问。在6968名按时赴约并接受筛查的参与者中，6678人被随机分配(4451人被分配为参与者，2227人被分配为非参与者;平均年龄28岁;59%的女性);88%的与会者(3917)和87%的非与会者(1947)遵守了后续要求。第7天，3917名参与者中有8人RT-PCR阳性(观察发病率为0·20%;95% CI 0·09-0·40)和1947个非与会者中的3个(0·15%;0·03-0·45;绝对差异，95% CI−0·26%至0·28%)，结果满足主要终点的非劣效性标准。

结论：

在没有保持身体距离的情况下，参与大型室内现场集会未增加新冠传播风险，前提是实施了全面的预防干预。

图1 在集会期间佩戴口罩的总体遵守情况

Background

Mass indoor gatherings were banned in early 2020 to prevent the spread of SARS-CoV-2. We aimed to assess, under controlled conditions, whether infection rates among attendees at a large, indoor gathering event would be similar to those in non-attendees, given implementation of a comprehensive prevention strategy including antigen-screening within 3 days, medical mask wearing, and optimised ventilation.

Methods

The non-inferiority, prospective, open-label, randomised, controlled SPRING trial was done on attendees at a live indoor concert held in the Accor Arena on May 29, 2021 in Paris, France. Participants, aged 18–45 years, recruited via a dedicated website, had no comorbidities, COVID-19 symptoms, or recent case contact, and had had a negative rapid antigen diagnostic test within 3 days before the concert. Participants were randomly allocated in a 2:1 ratio to the experimental group (attendees) or to the control group (non-attendees). The allocation sequence was computer-generated by means of permuted blocks of sizes three, six, or nine, with no stratification. The primary outcome measure was the number of patients who were SARS-CoV-2-positive by RT-PCR test on self-collected saliva 7 days post-gathering in the per-protocol population (non-inferiority margin <0·35%).

Findings

Between May 11 and 25, 2021, 18 845 individuals registered on the dedicated website, and 10 953 were randomly selected for a pre-enrolment on-site visit. Among 6968 who kept the appointment and were screened, 6678 participants were randomly assigned (4451 were assigned to be attendees and 2227 to be non-attendees; median age 28 years; 59% women); 88% (3917) of attendees and 87% (1947) of non-attendees complied with follow-up requirements. The day 7 RT-PCR was positive for eight of the 3917 attendees (observed incidence, 0·20%; 95% CI 0·09–0·40) and three of the 1947 non-attendees (0·15%; 0·03–0·45; absolute difference, 95% CI −0·26% to 0·28%), findings that met the non-inferiority criterion for the primary endpoint.

Interpretation

Participation in a large, indoor, live gathering without physical distancing was not associated with increased SARS-CoV-2–transmission risk, provided a comprehensive preventive intervention was implemented.

Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infectious disease. November 26, 2021