National Institute for Public Health and the Environment (RIVM), Center for Infectious Disease Control, Bilthoven, The Netherlands
National Institute for Public Health and the Environment (RIVM), Center for Infectious Disease Control, Bilthoven, The Netherlands.
BMJ Open. 2022 Jul 1;12(7):e062439. doi: 10.1136/bmjopen-2022-062439.
A substantial proportion of individuals infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), report persisting symptoms weeks and months following acute infection. Estimates on prevalence vary due to differences in study designs, populations, heterogeneity of symptoms and the way symptoms are measured. Common symptoms include fatigue, cognitive impairment and dyspnoea. However, knowledge regarding the nature and risk factors for developing persisting symptoms is still limited. Hence, in this study, we aim to determine the prevalence, severity, risk factors and impact on quality of life of persisting symptoms in the first year following acute SARS-CoV-2 infection.
The LongCOVID-study is both a prospective and retrospective cohort study being conducted in the Netherlands, with a one year follow-up. Participants aged 5 years and above, with self-reported positive or negative tests for SARS-CoV-2 will be included in the study. The primary outcome is the prevalence and severity of persistent symptoms in participants that tested positive for SARS-CoV-2 compared with controls. Symptom severity will be assessed for fatigue (Checklist Individual Strength (CIS subscale fatigue severity)), pain (Rand-36/SF-36 subscale bodily pain), dyspnoea (Medical Research Council (mMRC)) and cognitive impairment (Cognitive Failure Questionnaire (CFQ)). Secondary outcomes include effect of vaccination prior to infection on persistent symptoms, loss of health-related quality of life (HRQoL) and risk factors for persisting symptoms following infection with SARS-CoV-2.
The Utrecht Medical Ethics Committee (METC) declared in February 2021 that the Medical Research Involving Human Subjects Act (WMO) does not apply to this study (METC protocol number 21-124/C). Informed consent is required prior to participation in the study. Results of this study will be submitted for publication in a peer-reviewed journal.
相当一部分感染严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的个体在急性感染后数周和数月仍有持续症状。由于研究设计、人群、症状异质性以及症状测量方式的不同，患病率的估计值存在差异。常见症状包括疲劳、认知障碍和呼吸困难。然而，对于持续症状的性质和风险因素的了解仍然有限。因此，在这项研究中，我们旨在确定急性 SARS-CoV-2 感染后一年内持续症状的患病率、严重程度、风险因素和对生活质量的影响。
LongCOVID 研究是一项在荷兰进行的前瞻性和回顾性队列研究，随访时间为一年。将纳入年龄在 5 岁及以上、自我报告 SARS-CoV-2 检测阳性或阴性的参与者。主要结局是与对照组相比，SARS-CoV-2 检测阳性的参与者中持续症状的患病率和严重程度。将使用 Checklist Individual Strength（CIS 疲劳严重程度子量表）评估疲劳、使用 Rand-36/SF-36（身体疼痛子量表）评估疼痛、使用 Medical Research Council（mMRC）评估呼吸困难和使用 Cognitive Failure Questionnaire（CFQ）评估认知障碍来评估症状严重程度。次要结局包括感染前疫苗接种对持续症状的影响、健康相关生活质量（HRQoL）损失以及 SARS-CoV-2 感染后持续症状的风险因素。
乌得勒支医学伦理委员会（METC）于 2021 年 2 月宣布，《涉及人体医学研究的法律》（WMO）不适用于这项研究（METC 协议编号 21-124/C）。在参与研究之前需要获得知情同意。本研究的结果将提交给同行评议期刊发表。
