Dysfunction of Olfaction After SARS-CoV-2 Infection: Morphological and Histomolecular Investigation of Olfactory Cleft Biopsies and Cytobrushes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 14
- 主要终点
- Analysis of olfactory cleft biopsies
研究概览
简要总结
Investigation of the mechanisms of persistent SARS-CoV-2 associated olfactory dysfunction (OD) in patients with well-documented olfactory function. The investigators plan to collect olfactory cleft biopsies and cytobrushes in COVID-19 patients and controls.
详细描述
An explorative prospective clinical study using human body materials of living post-COVID-19 patients with and without OD, to study the mechanisms of persisting olfactory dysfunction. Patients consult ENT specialist for medical purposes and undergo standard-of-care diagnostics and management. The collected tissues from the olfactory cleft mucosa will be analyzed using single cell RNA sequencing and RNAscope combined with immunohistochemistry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Olfactory Dysfunction group: Presence of evident OD (Parosmia, Threshold-Discrimination-Identification (TDI)-score ≤24, Subjective abnormal quantitative olfactory function; measured by a visual analogue score (VAS) of smell impairment ≥5/10
- •Control group: No OD (TDI-score >30.5.)
排除标准
- •Presence of concomitant nasal mucosal pathology that might affect olfactory function or bias the study investigations
- •Use of anticoagulation therapy
- •Allergy to local anesthetics
研究组 & 干预措施
Control
Biopsy and cytobrush during a scheduled structural intervention in general anesthesia
干预措施: Biopsy and Cytobrush (Procedure)
Olfactory Dysfunction
Biopsy and cytobrush during consultation in local anesthesia
干预措施: Biopsy and Cytobrush (Procedure)
结局指标
主要结局
Analysis of olfactory cleft biopsies
时间窗: From enrollment of 1 patient until analyzed, 1 month
Morphological and histomolecular differences between OD and control patients * Evaluating tissue pathology: * Metaplasia * hypertrophy * aberrant scar formation * apoptosis * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\] * Presence of SARS-CoV-2 RNA * Percentage of OSNs versus sustentacular cells; maturation of OSNs
Analysis of olfactory cytobrushes
时间窗: From enrollment of 1 patient until analyzed, 1 month
Morphological and histomolecular differences between OD and control patients * Evaluating tissue pathology: * Metaplasia * hypertrophy * aberrant scar formation * apoptosis * presence of inflammatory cells \[H\&E, CD68 and CD3 stainings, RNAscope\] * Presence of SARS-CoV-2 RNA * In the olfactory epithelium: percentage of OSNs versus sustentacular cells; maturation of OSNs
次要结局
未报告次要终点