INCIDENCE, PREDICTORS, AND CLINICAL OUTCOMES OF SARS-CoV-2 INFECTION IN PERSONS WITH HIV

新冠肺炎是由SARS-CoV-2病毒引起的一种疾病，在美国尚未被描述为艾滋病毒携带者(PWH)的临床表现和严重程度。了解新冠肺炎在PWH中的表现谱和人群特有的危险因素至关重要。威斯康星会改变免疫反应，可能会增加新冠肺炎并发症和死亡的风险。在美国，近一半的威斯康星患者年龄在50岁或以上，他们中的许多人都患有多种并存疾病，包括糖尿病、高血压、心血管疾病和乙型或丙型肝炎病毒混合感染，其中每一种都可能增加严重新冠肺炎疾病和死亡的风险。拟议的研究将建立在多地点CFAR综合临床系统网络(CNIC)队列中预期收集和验证的数据的强大基础设施和研究平台上，以调查美国各地常规护理中地理和人口结构多样化的PWH人群中新冠肺炎的风险因素和临床表现。这一补充将使我们能够迅速加强CNICS的数据收集(诊断、实验室、用药和程序数据)和病历审查程序，以确保收集和判断相关的临床因素(例如同时使用血管紧张素转换酶抑制剂和直接作用的抗病毒药物)、基线并存情况、疾病严重程度的指标(例如住院事件、呼吸系统、心脏、血栓、血液系统、炎症和肾脏后果)以及新冠肺炎的转归，以确定威斯康星医院实验室确认的新冠肺炎病例的特征。我们将调查威尔斯亲王医院中与PCR阳性SARS-CoV-2感染相关的观察发病率、严重临床结局的预测因素(住院、ICU入院、插管)和死亡率。我们亦会利用透过常规护理获得的SARS-CoV-2血清学测试数据，估计出现轻微症状或无症状血清转换为SARS-CoV-2的威尔斯亲王的比例。我们的首要假设是，新冠肺炎病的严重程度在威斯康星患者中将高于普通人群，特别是在那些可检测到艾滋病毒病毒血症、CD_4细胞计数低、以及包括肥胖、糖尿病、心血管疾病、肝脏和肺部疾病在内的较高共病负担的人群中。这一补充利用了CNICs提供的全面数据，并利用了快速合并新数据元素和判定新的临床结果的能力。

Clinical manifestations and severity of COVID-19, the disease caused by SARS-CoV-2, in persons with HIV (PWH) have not been described in the United States (US). It is of critical importance to understand the spectrum of manifestations of COVID-19 in PWH and population-specific risk factors. PWH have altered immune responses and may be at higher risk for complications and death from COVID-19. Nearly half of PWH in the US are aged 50 or older, and many of them are affected by multiple comorbidities including diabetes, hypertension, cardiovascular disease (CVD), and hepatitis B or C virus coinfection, each of which may also increase risk of severe COVID-19 disease and death. The proposed research will build on the robust infrastructure and research platform of prospectively-collected and validated data in the multi-site CFAR Network of Integrated Clinical Systems (CNICS) cohort to investigate risk factors and clinical manifestations of COVID-19 in a geographically and demographically diverse population of PWH in routine care across the US. This supplement will enable us to rapidly augment CNICS data collection (diagnoses, laboratory, medication and procedure data) and medical record review procedures to ensure that relevant clinical factors (e.g. concomitant use of angiotensin-converting enzyme inhibitors and direct-acting antiviral agents), baseline comorbidities, indicators of disease severity (e.g. in-hospital incident respiratory, cardiac, thrombotic, hematologic, inflammatory, and renal consequences), and outcomes of COVID-19 are captured and adjudicated to characterize laboratory-confirmed COVID-19 cases occurring in PWH. We will investigate the observed incidence, predictors of severe clinical outcomes (hospitalization, ICU admission, intubation), and mortality associated with PCR-positive SARS-CoV-2 infection among PWH. Using SARS-CoV-2 serologic testing data obtained through routine care, we will also estimate the proportion of PWH who had minimally symptomatic or asymptomatic seroconversion to SARS-CoV-2. Our overarching hypothesis is that the severity of COVID-19 disease will be higher among PWH than in the general population, particularly among those with detectable HIV viremia, low CD4 cell count, and higher comorbidity burden including obesity, diabetes, CVD, liver and lung disease. This supplement leverages the comprehensive data available in CNICS and takes advantage of the ability to rapidly incorporate new data elements and adjudicate novel clinical outcomes.