Effects of COVID-19 in Patients with Gastroparesis: A GpCRC Supplement

摘要： 2019冠状病毒病（COVID-19），一种由严重急性呼吸道感染引起的疾病 冠状病毒2型综合征（SARS-CoV-2），通常表现为发热、咳嗽和 呼吸急促。一些患者在发生胃肠道疾病后， (GI)症状单独或与肺部症状一起。这可能是由于SARS-CoV-2 胃肠道感染或呼吸道病毒感染的全身效应。慢性GI患者 疾病，如胃轻瘫，COVID-19可能表现为潜在胃肠道疾病的发作， 病毒在历史上与慢性胃肠道疾病（包括胃轻瘫）的恶化有关。 一些没有基础胃肠道疾病的患者在就诊后被诊断为COVID-19 主要是恶心呕吐和腹泻他们可能会有病毒感染后 胃轻瘫，这是一个重要的和知之甚少的潜在慢性炎症为基础的原因， “特发性胃轻瘫”NIH胃轻瘫临床研究联盟（GpCRC），由六个 临床中心及其科学和数据研究中心（SDRC），是继最大数量的 有胃轻瘫和消化不良症状的患者。这些患者具有良好的表型。除了 详细的生理表型，每6个月我们获得详细的问卷调查，并储存血浆 和血清。这项补充拨款的总体目标是确定COVID-19是否影响临床 胃轻瘫患者的病程以及COVID-19是否与胃轻瘫的发生相关 感染后胃轻瘫和/或功能性消化不良。我们将通过以下方式实现这些目标： 在我们的胃轻瘫登记处中涉及患者的以下三个具体目标。目标1. 确定确诊胃轻瘫患者中SARS-CoV-2感染的患病率，以帮助评估 如果SARS-CoV-2感染对胃轻瘫患者的影响不成比例， 在同一地理位置的社区。目的2：确定COVID-19是否影响临床 胃轻瘫患者的病程通过引起比平时更多的发作，增加 胃轻瘫症状和胃排空减少。目的3：描述患者出现新的 COVID-19后患者的胃轻瘫发作和功能性消化不良。目前，GpCRC是唯一一家 NIH资助的一项大型胃动力障碍（胃轻瘫）慢性GI症状患者登记研究。的 SARS-CoV-2累及胃肠道上皮以及此类感染可导致 慢性肠道功能障碍，使GpCRC理想地准备进行这项研究。该研究项目将 在1年时间轴内完成，以产生有影响力的临床数据，从而了解 SARS-CoV-2感染。这项拟定研究将在GpCRC的所有6个临床研究中心实施， SDRC协调中心和GpCRC的马约诊所中心将用于SARS-CoV-2血清学检测。

ABSTRACT: Coronavirus Disease 2019 (COVID-19), a disease caused by infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), commonly presents with symptoms including fever, cough, and shortness of breath. Some patients have tested positive for SARS-CoV-2 after developing gastrointestinal (GI) symptoms either solely or in conjunction with pulmonary symptoms. This may be due to SARS-CoV-2 infection of the GI tract or a systemic effect from the respiratory viral infection. In patients with chronic GI illnesses, such as gastroparesis, COVID-19 may present as a flare of their underlying GI condition as viruses have historically been implicated in exacerbations of chronic GI disorders, including gastroparesis. Some patients with no underlying GI conditions have been diagnosed with COVID-19 after presenting predominantly with nausea, vomiting and diarrhea. They may be at risk for developing post-viral gastroparesis, which is an important and poorly understood potential chronic inflammation-based cause of “idiopathic gastroparesis”. The NIH Gastroparesis Clinical Research Consortium (GpCRC), consisting of six clinical centers and its Scientific and Data Research Center (SDRC), is following the largest number of patients with gastroparesis and dyspepsia symptoms. These patients are well phenotyped. In addition to detailed physiological phenotyping, every 6 months we obtain detailed questionnaires, and store plasma and serum. The overall goals of this supplemental grant are to determine if COVID-19 affects clinical course of patients with gastroparesis and whether COVID-19 is associated with development of post-infection gastroparesis and/or functional dyspepsia. We will accomplish these goals by undertaking the following three specific aims involving patients in our gastroparesis registry. Aim 1. Determine the prevalence of SARS-CoV-2 infection in patients with confirmed gastroparesis to help assess if SARS-CoV-2 infection disproportionately affects patients with gastroparesis compared to general community population in same geographic location. Aim 2: Determine if COVID-19 affects the clinical course of patients with gastroparesis by causing more flares than usual, increasing the severity of gastroparesis symptoms, and decreasing gastric emptying. Aim 3: Characterize patients developing new onset gastroparesis and functional dyspepsia after COVID-19 in patients. Currently, the GpCRC is the only large, NIH-funded registry of patients with chronic GI symptoms from gastric dysmotility (gastroparesis). The GI epithelial involvement with SARS-CoV-2 as well as the existing rationale that such infections can led to chronic gut dysfunction, makes GpCRC ideally poised to conduct this research. This research project will be accomplished within 1 year timeline to produce impactful clinical data to understand GI implications of SARS-CoV-2 infection. This proposed study will be implemented at all six clinical sites of the GpCRC with SDRC for coordination and Mayo Clinic core of the GpCRC will be used for SARS-CoV-2 serology testing.