Institute of General Practice, Medical Faculty, University of Duisburg-Essen Faculty of Medicine, Essen, Germany.
Department of Sports Medicine, Rehabilitation and Disease Prevention, Johannes Gutenberg Universitat Mainz, Mainz, Germany.
BMJ Open. 2022 Jun 16;12(6):e058647. doi: 10.1136/bmjopen-2021-058647.
The clinical course of patients with a SARS-CoV-2 (COVID-19) infection varies widely, from symptom-free to severe courses that can lead to death. Laboratory values of SARS-CoV-2 patients such as lymphocyte counts or C-reactive protein (CRP) do not allow a prediction of the actual course of the disease. To identify a possible predictive marker for the differentiation and prognosis of illness with influenza-like symptoms with and without SARS-CoV-2 infections in general practice, we will analyse the concentrations of cell-free DNA (cfDNA) levels, laboratory and clinical parameters, temperature, oxygen saturation, breathing rate and concomitant symptoms in patients with flu-like symptoms with and without a SARS-CoV-2 infection.
This is a single-centre, two-arm, parallel longitudinal cohort study with a total of 44 patients. 22 patients with flu-like symptoms without a SARS-CoV-2 infection and 22 patients with flu-like symptoms with a SARS-CoV-2 infection will be recruited. The primary objective is to compare cfDNA levels in ambulatory patients in general practice with flu-like symptoms with SARS-CoV-2 infection with those with influenza like symptoms without a SARS-CoV-2 infection during the disease (day 7 and day 14). The secondary objective is to determine whether there is a correlation between cfDNA concentrations on the one hand, and laboratory and clinical parameters on the other hand. cfDNA, differential blood count, high-sensitive CRP and erythrocyte sedimentation rate will be measured in blood samples, concomitant symptoms will be surveyed via a self-assessment questionnaire, and oxygen saturation, breathing rate and examination of the lungs will be reported by treating physicians.
Ethical approval was issued on 1 March 2021 by the Ethics Committee Essen under the number 21-9916-BO. Findings will be published in peer-reviewed open-access journals and presented at national and international conferences.
DRKS00024722.
感染 SARS-CoV-2（COVID-19）的患者的临床病程差异很大，从无症状到可导致死亡的严重病程不等。SARS-CoV-2 患者的实验室值，如淋巴细胞计数或 C 反应蛋白（CRP），无法预测疾病的实际病程。为了确定一般实践中具有流感样症状的 SARS-CoV-2 感染和非 SARS-CoV-2 感染患者的疾病分化和预后的可能预测标志物，我们将分析具有和不具有 SARS-CoV-2 感染的流感样症状患者的无细胞 DNA（cfDNA）水平、实验室和临床参数、体温、氧饱和度、呼吸频率和伴随症状的浓度。
这是一项单中心、双臂、平行纵向队列研究，共有 44 名患者。将招募 22 名具有流感样症状但无 SARS-CoV-2 感染的患者和 22 名具有流感样症状且有 SARS-CoV-2 感染的患者。主要目的是比较一般实践中具有 SARS-CoV-2 感染的流感样症状患者和无 SARS-CoV-2 感染的流感样症状患者在疾病期间（第 7 天和第 14 天）的 cfDNA 水平。次要目的是确定 cfDNA 浓度与实验室和临床参数之间是否存在相关性。将在血液样本中测量 cfDNA、差异血细胞计数、高敏 CRP 和红细胞沉降率，通过自我评估问卷调查伴随症状，并由治疗医生报告氧饱和度、呼吸频率和肺部检查。
伦理委员会于 2021 年 3 月 1 日批准了该研究，注册号为 DRKS00024722。研究结果将发表在同行评议的开放获取期刊上，并在国内外会议上展示。
