Wu Shan, Luo Zhaoyao, Liu Huiping, Zhu Jia, Zhu Yanan, Hou Danwei, Wei Tianhua, Liu Tonghui, Zheng Chao, Zhu Zhimin, Huang Weipeng, Bai Weixian, Yu Xinyi, Yuan Huijie, Bao Wenrui, Zhang Ming, Niu Xuan
Department of Medical Imaging, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, China.
BMJ Open. 2025 Jan 22;15(1):e083023. doi: 10.1136/bmjopen-2023-083023.
During the first wave of the COVID-19 outbreak in China, the surge of COVID-19 cases was rapid and drastic. Emerging evidence suggests that beyond the acute phase, patients with COVID-19 may experience a wide range of postacute or long COVID sequelae. However, the mechanism and burden of COVID-19, especially long COVID, have not yet been comprehensively clarified. To fill this knowledge gap, this large prospective follow-up study aims to investigate the short-term and long-term effects of COVID-19, explore the underlying biological mechanism and identify predictive neuroimaging and haematological biomarkers associated with these effects.
This multicentre study will recruit patients infected during the first wave of COVID-19 in China and healthy controls (HCs) with no history of COVID-19 infection from nine participating hospitals. Confirmed patients with mild or moderate COVID-19 will complete the following programmes during the acute infection phase and at 3, 12 and 24 months after infection: (a) blood test at the local laboratory, (b) multimodal brain and spine MRI scan and (c) the neuropsychological scales and questionnaires. Similarly, the uninfected HCs will complete the same programmes as the infected group mentioned above at the time of inclusion. At the first time point, 501 participants (418 patients and 83 HCs) from nine recruiting hospitals have been observed. Ultimately, all of these results will be analysed to explore the short-term and long-term effects of COVID-19.
Ethics approval was granted by Ethics Committee of the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2023LSK-013). Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals.
NCT05745805.
在中国新冠疫情的第一波暴发期间,新冠病例激增迅速且剧烈。新出现的证据表明,在急性期过后,新冠患者可能会经历广泛的急性后或长期新冠后遗症。然而,新冠尤其是长期新冠的机制和负担尚未得到全面阐明。为填补这一知识空白,这项大型前瞻性随访研究旨在调查新冠的短期和长期影响,探索潜在的生物学机制,并确定与这些影响相关的预测性神经影像学和血液生物标志物。
这项多中心研究将招募在中国新冠疫情第一波期间感染的患者以及来自9家参与医院的无新冠感染史的健康对照者。确诊的轻症或中症新冠患者将在急性感染期以及感染后3个月、12个月和24个月完成以下项目:(a)在当地实验室进行血液检测,(b)多模态脑和脊柱磁共振成像扫描,(c)神经心理学量表和问卷。同样,未感染的健康对照者将在纳入研究时完成与上述感染组相同的项目。在第一个时间点,已观察到来自9家招募医院的501名参与者(418名患者和83名健康对照者)。最终,将对所有这些结果进行分析,以探索新冠的短期和长期影响。
西安交通大学第一附属医院伦理委员会已批准本研究(XJTU1AF2023LSK - 013)。研究结果将在国内和国际会议上展示,并发表在同行评审的科学期刊上。
NCT05745805。