Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study.
Impact of Chronic Use of Antimalarials on SARS-CoV-2 Infection in Patients With Immune-Mediated Rheumatic Diseases: Protocol for a Multicentric Observational Cohort Study.
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DOI：
10.2196/23532
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发表时间：
2020-10-14
影响因子：
1.7
通讯作者：
Pinheiro M
中科院分区：
文献类型：
--
作者：
Gomides A;Ferreira G;Kakehasi A;Lacerda M;Marques C;Mota L;Paiva E;Pileggi G;Provenza J;Reis-Neto E;Sampaio V;Xavier R;Pinheiro M
由SARS-CoV-2病毒引起的COVID-19近几个月来给科学界带来了广泛的挑战。已经进行了几项研究，试图尽量减少这种疾病在世界范围内的影响。虽然新的知识已经迅速传播，包括病毒机制，病理生理学和临床发现，但缺乏关于这种疾病的有效药物管理的信息。体外研究表明，使用抗疟药（氯喹和羟氯喹）抑制SARS-CoV-2有一些益处。然而，来自COVID-19患者的开放临床试验的数据存在争议。我们提出了一个研究项目的方案，该研究项目比较了抗疟药在预防两组中度至重度COVID-19中的潜在保护作用：（1）长期接受抗疟药治疗风湿性疾病的患者和（2）未被诊断患有风湿性疾病且未服用抗疟药的患者家庭其他成员。这是一项为期24周的前瞻性观察性队列研究，研究对象包括来自巴西各地公共和私人卫生服务机构的患者，这些患者长期使用抗疟药治疗免疫介导的风湿性疾病、骨关节炎或基孔肯雅病相关关节病。于2019冠状病毒病爆发期间，我们在巴西五个不同地区安排了共六次连续电话采访。有关社会、流行病学和人口统计学数据的信息，以及有关风湿性疾病、抗疟药、合并症和合并用药的详细信息，正在使用REDCap数据库中的特定在线表格进行记录。疑似COVID-19的症状，包括发热、咳嗽、呼吸困难、嗅觉丧失和味觉障碍，正在通过电话采访进行自我报告和收集。我们的主要结果是住院，需要重症监护室和死亡。招募于2020年3月底开始，在8周的时间内（从3月29日至5月17日）完成，共有10，443名基线入组的个体，其中5166人患有风湿性疾病，来自97个巴西城市的23个三级风湿病中心。计划在收集所有入选数据后开始进行数据分析。这项研究，其中包括一个大样本的慢性抗疟药使用者，将使我们能够探索SARS-CoV-2感染是否可能与免疫介导的风湿性疾病和长期抗疟药的使用。巴西临床试验注册中心RBR-9 KTWX 6; http://www.ensaiosclinicos.gov.br/rg/RBR-9ktwx6/ DERR 1 -10.2196/23532
COVID-19, caused by the virus SARS-CoV-2, has brought extensive challenges to the scientific community in recent months. Several studies have been undertaken in an attempt to minimize the impact of the disease worldwide. Although new knowledge has been quickly disseminated, including viral mechanisms, pathophysiology, and clinical findings, there is a lack of information on the effective pharmacological management of this disease. In vitro studies have shown some benefits related to the use of antimalarials (chloroquine and hydroxychloroquine) for inhibiting SARS-CoV-2. However, the data from open clinical trials on COVID-19 patients are controversial. We present the protocol for a research project that compares the potential protective effect of antimalarials in preventing moderate-to-severe forms of COVID-19 in two groups: (1) patients treated chronically with antimalarials for rheumatic diseases and (2) other members of the patients’ household who have not been diagnosed with rheumatic diseases and are not taking antimalarials. This is a 24-week, prospective, observational cohort study comprising patients from public and private health services across Brazil, who chronically use antimalarials for the treatment of immune-mediated rheumatic diseases, osteoarthritis, or chikungunya-related arthropathy. A total of six sequential phone interviews were scheduled during the COVID-19 outbreak in five different regions of Brazil. Information regarding social, epidemiological, and demographic data, as well as details about rheumatic diseases, antimalarials, comorbidities, and concomitant medication, is being recorded using a specific online form in the REDCap database. Symptoms suggestive of COVID-19, including fever, cough, dyspnea, anosmia, and dysgeusia, are being self-reported and collected via phone interviews. Our main outcomes are hospitalization, need of intensive care unit, and death. Recruitment began at the end of March 2020, and the inclusion was done during an 8-week period (from March 29 to May 17) with a total of 10,443 individuals enrolled at baseline, 5166 of whom have rheumatic diseases, from 23 tertiary rheumatology centers across 97 Brazilian cities. Data analysis is scheduled to begin after all inclusion data have been collected. This study, which includes a large sample of chronic antimalarial users, will allow us to explore whether SARS-CoV-2 infection may be associated with immune-mediated rheumatic diseases and long-term antimalarial usage. Brazilian Registry of Clinical Trials RBR–9KTWX6; http://www.ensaiosclinicos.gov.br/rg/RBR-9ktwx6/ DERR1-10.2196/23532
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影响因子：
14.6
作者：
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通讯作者：
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DOI：
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影响因子：
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