Daily testing for contacts of individuals with SARS-CoV-2 infection and attendance and SARS-CoV-2 transmission in English secondary schools and colleges: an open-label, cluster-randomised trial.
Daily testing for contacts of individuals with SARS-CoV-2 infection and attendance and SARS-CoV-2 transmission in English secondary schools and colleges: an open-label, cluster-randomised trial.
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DOI：
10.1016/s0140-6736(21)01908-5
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发表时间：
2021-10-02
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通讯作者：
Peto TEA
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作者：
Young BC;Eyre DW;Kendrick S;White C;Smith S;Beveridge G;Nonnenmacher T;Ichofu F;Hillier J;Oakley S;Diamond I;Rourke E;Dawe F;Day I;Davies L;Staite P;Lacey A;McCrae J;Jones F;Kelly J;Bankiewicz U;Tunkel S;Ovens R;Chapman D;Bhalla V;Marks P;Hicks N;Fowler T;Hopkins S;Yardley L;Peto TEA
英格兰学校的COVID-19接触者被要求在家中自我隔离，错过了关键的教育机会。我们尝试每天对接触者进行检测，作为一种替代方法，以评估这是否会导致类似的传播控制，同时允许更多的学校入学。我们在英格兰的中学和继续教育学院进行了一项开放标签、随机分组、对照试验。学校被随机分配（1：1），对学校的COVID-19接触者进行自我隔离10天（对照），或自愿每天进行横向流动装置（LFD）检测7天，LFD阴性接触者留在学校（干预）。根据学校类型和规模，六年级的存在，住宿学生的存在，以及有资格获得免费校餐的学生比例进行随机分层。在程序或分析期间未设盲分组。所有学生和教职员工的共同主要结果是COVID-19相关的缺课和症状性PCR证实的COVID-19，根据社区病例率进行调整，以估计校内传播（非劣效性界值<50%相对增加）。分析是在意向治疗的基础上进行的，使用拟泊松回归，也估计了复杂的平均因果效应（CACE）。本试验已在ISRCTN登记研究（ISRCTN 18100261）中注册。在2021年3月18日至5月4日期间，204所学校通过了同意程序，其中三所学校决定不再参与。在为期10周的研究（2021年4月19日至5月10日）中随机分配了201所学校（对照组n=99，干预组n=102），该研究持续到预先指定的停止日期（2021年6月27日）。76所对照组学校和86所干预组学校积极参与;更多的国家数据允许大多数未参与的学校被纳入共同主要结果的分析。在5763名干预组接触者中，2432人（42.4%）参加了日常接触测试。在7782537天的风险期内，有657例症状性PCR确认的感染（59·1/100000/周），在8379749天的风险期内，（61·8/10万/周）（意向治疗校正的发生率比[aIRR] 0·96 [95% CI 0·75-1·22]; p=0·72; CACE aIRR 0·86 [0·55-1·34]）。在学生和教职员中，对照组在3 659 017人上学日中有59 422人（1.62%）与COVID-19相关的缺勤，干预组在3 845 208人上学日中有51 541人（1.34%）与COVID-19相关的缺勤（意向治疗aIRR 0.80 [95% CI 0.54 - 1.19]; p= 0.27; CACE aIRR 0.61 [0.30 - 1.23]）。在控制COVID-19传播方面，学校接触者的日常接触检测并不劣于自我隔离，两种方法在学生和员工中的症状感染率相似。学校接触者的感染率很低，很少有学校接触者检测呈阳性。应考虑实施每日接触测试，作为学校接触后居家隔离的安全替代方案。英国政府卫生和社会保健部。
School-based COVID-19 contacts in England have been asked to self-isolate at home, missing key educational opportunities. We trialled daily testing of contacts as an alternative to assess whether this resulted in similar control of transmission, while allowing more school attendance. We did an open-label, cluster-randomised, controlled trial in secondary schools and further education colleges in England. Schools were randomly assigned (1:1) to self-isolation of school-based COVID-19 contacts for 10 days (control) or to voluntary daily lateral flow device (LFD) testing for 7 days with LFD-negative contacts remaining at school (intervention). Randomisation was stratified according to school type and size, presence of a sixth form, presence of residential students, and proportion of students eligible for free school meals. Group assignment was not masked during procedures or analysis. Coprimary outcomes in all students and staff were COVID-19-related school absence and symptomatic PCR-confirmed COVID-19, adjusted for community case rates, to estimate within-school transmission (non-inferiority margin <50% relative increase). Analyses were done on an intention-to-treat basis using quasi-Poisson regression, also estimating complier average causal effects (CACE). This trial is registered with the ISRCTN registry, ISRCTN18100261. Between March 18 and May 4, 2021, 204 schools were taken through the consent process, during which three decided not to participate further. 201 schools were randomly assigned (control group n=99, intervention group n=102) in the 10-week study (April 19–May 10, 2021), which continued until the pre-appointed stop date (June 27, 2021). 76 control group schools and 86 intervention group schools actively participated; additional national data allowed most non-participating schools to be included in analysis of coprimary outcomes. 2432 (42·4%) of 5763 intervention group contacts participated in daily contact testing. There were 657 symptomatic PCR-confirmed infections during 7 782 537 days-at-risk (59·1 per 100 000 per week) in the control group and 740 during 8 379 749 days-at-risk (61·8 per 100 000 per week) in the intervention group (intention-to-treat adjusted incidence rate ratio [aIRR] 0·96 [95% CI 0·75–1·22]; p=0·72; CACE aIRR 0·86 [0·55–1·34]). Among students and staff, there were 59 422 (1·62%) COVID-19-related absences during 3 659 017 person-school-days in the control group and 51 541 (1·34%) during 3 845 208 person-school-days in the intervention group (intention-to-treat aIRR 0·80 [95% CI 0·54–1·19]; p=0·27; CACE aIRR 0·61 [0·30–1·23]). Daily contact testing of school-based contacts was non-inferior to self-isolation for control of COVID-19 transmission, with similar rates of symptomatic infections among students and staff with both approaches. Infection rates in school-based contacts were low, with very few school contacts testing positive. Daily contact testing should be considered for implementation as a safe alternative to home isolation following school-based exposures. UK Government Department of Health and Social Care.