Prophylactic Treatment of COVID-19 in Care Homes Trial (PROTECT-CH)
Prophylactic Treatment of COVID-19 in Care Homes Trial (PROTECT-CH)
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护理院试验中的 COVID-19 预防性治疗 (PROTECT-CH)
DOI：
10.1101/2022.08.29.22279359
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Bath P
中科院分区：
文献类型：
--
作者：
Bath P
2019冠状病毒病（COVID-19）与养老院的死亡率和发病率显著相关。新型或改换用途的抗病毒药物可以通过减少病毒复制和炎症来降低感染和疾病严重程度。目的比较两种抗病毒药物（环来奈德、硝氯胺）预防养老院居民SARS-CoV-2感染和COVID-19严重程度的安全性和有效性。designcluster随机开放标签盲法终点平台临床试验，在暴露后预防范例中测试抗病毒药物。在英国所有四个成员国设立养老院。参与者是65岁或以上的家庭居民。干预家庭将通过计算机随机分配到42天的抗病毒药物加标准护理与标准护理，随机化后随访60天。主要结局指标：根据最严重的全因死亡、全因住院、SARS-CoV-2感染和未感染对参与者进行分类的主要4级有序分类结局。采用有序逻辑回归进行分析。其他结果包括主要结果和传播的组成部分。结果国家卫生研究院与潜在抗病毒药物生产商之间的合同延迟显著推迟了任何可能的开始日期。在确定了试验（方案、批准、保险、网站、数据库、常规数据算法、培训材料）之后，鉴于在护理院成功接种疫苗，大大减少了感染、住院和死亡，在与护理院和全科医生签约之前，试验于2021年9月停止。因此，样本量目标（基于2020年2月至6月的COVID-19发病率和死亡人数）变得不可行。限制：没有联系到这些家庭居民，因此他们没有同意，也没有接受治疗。因此，筛查、同意、治疗和数据获取的可行性以及暴露后预防的潜在益处从未得到测试。此外，诺丁汉大学与pi、gp和护理院之间的合同还没有完成，因此没有测试与所有不同群体在所需规模上签订合同的可行性。由于疫苗接种计划改变了COVID-19的发病率、流行率和毒力，使得研究不可行，因此未对养老院居民暴露后预防COVID-19的作用进行测试。在描述和发展基础设施必要的大规模临床试验的研究药品在护理之家在所有四个英国国家取得了重大进展。COVID-19暴露后预防在养老院居民中的作用仍有待确定。在大流行期间在护理院进行研究的重大后勤障碍需要消除，然后才能在所需的短时间内进行此类研究。
BackgroundCoronavirus disease 2019 (COVID-19) is associated with significant mortality and morbidity in care homes. Novel or repurposed antiviral drugs may reduce infection and disease severity through reducing viral replication and inflammation.ObjectiveTo compare the safety and efficacy of antiviral agents (ciclesonide, niclosamide) for preventing SARS-CoV-2 infection and COVID-19 severity in care home residents.DesignCluster-randomised open-label blinded endpoint platform clinical trial testing antiviral agents in a post-exposure prophylaxis paradigm.SettingCare homes across all four United Kingdom member countries.ParticipantsCare home residents 65 years of age or older.InterventionsCare homes were to be allocated at random by computer to 42 days of antiviral agent plus standard care versus standard of care and followed for 60 days after randomisation.Main outcome measuresThe primary four-level ordered categorical outcome with participants classified according to the most serious of all-cause mortality, all-cause hospitalisation, SARS-CoV-2 infection and no infection. Analysis using ordinal logistic regression was by intention to treat. Other outcomes included the components of the primary outcome and transmission.ResultsDelays in contracting between NIHR and the manufacturers of potential antiviral agents significantly delayed any potential start date. Having set up the trial (protocol, approvals, insurance, website, database, routine data algorithms, training materials), the trial was stopped in September 2021 prior to contracting of care homes and general practitioners in view of the success of vaccination in care homes with significantly reduced infections, hospitalisations and deaths. As a result, the sample size target (based on COVID-19 rates and deaths occurring in February-June 2020) became unfeasible.LimitationsCare home residents were not approached about the trial and so were not consented and did not receive treatment. Hence, the feasibility of screening, consent, treatment and data acquisition, and potential benefit of post exposure prophylaxis were never tested. Further, contracting between the University of Nottingham and the PIs, GPs and care homes was not completed, so the feasibility of contracting with all the different groups at the scale needed was not tested.ConclusionsThe role of post exposure prophylaxis of COVID-19 in care home residents was not tested because of changes in COVID-19 incidence, prevalence and virulence as a consequence of the vaccination programme that rendered the study unfeasible. Significant progress was made in describing and developing the infrastructure necessary for a large scale Clinical Trial of Investigational Medicinal Products in care homes in all four UK nations.Future workThe role of post-exposure prophylaxis of COVID-19 in care home residents remains to be defined. Significant logistical barriers to conducting research in care homes during a pandemic need to be removed before such studies are possible in the required short timescale.
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DOI：
10.1056/nejmoa2022926
发表时间：
2020-11-19
期刊：
The New England journal of medicine
影响因子：
--
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
通讯作者：
Landray MJ
BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
老年人中的 COVID-19：日本一家三级医院的回顾性队列研究
影响因子：
3.3
作者：
Tomoya Sano;Y. Kimizuka;Y. Fujikura;T. Hisada;Chie Watanabe;R. Suematsu;Kaori Izumi;Hiroaki Sugiura;J. Miyata;H. Shinmoto;Masayoshi Nagata;A. Kawana
通讯作者：
A. Kawana
DOI：
10.1056/nejmoa2035389
发表时间：
2021-02-04
期刊：
The New England journal of medicine
影响因子：
--
作者：
Baden LR;El Sahly HM;Essink B;Kotloff K;Frey S;Novak R;Diemert D;Spector SA;Rouphael N;Creech CB;McGettigan J;Khetan S;Segall N;Solis J;Brosz A;Fierro C;Schwartz H;Neuzil K;Corey L;Gilbert P;Janes H;Follmann D;Marovich M;Mascola J;Polakowski L;Ledgerwood J;Graham BS;Bennett H;Pajon R;Knightly C;Leav B;Deng W;Zhou H;Han S;Ivarsson M;Miller J;Zaks T;COVE Study Group
通讯作者：
COVE Study Group
效果：初步报告
DOI：
--
发表时间：
2012
期刊：
影响因子：
--
作者：
Yayota;M.;Kato;A.;Ohtani;S.
通讯作者：
S.