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

HIV 感染者感染 SARS-CoV-2 的发病率、预测因素和临床结果

• 批准号: 10305900
• 负责人: Michael S. Saag
• 金额: $ 18.66万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-06 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10305900
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adult; Area; Behavioral; Biological; Biological Specimen Banks; Biostatistics Core; Cardiac; Caring; Chronic; Clinic; Clinical; Clinical Data; Clinical Management; Collection; Communities; Complex; Computerized Medical Record; Consultations; Data; Day Care; Disease; Disease Progression; Distance Learning; Drug resistance; Epidemiology; Etiology; Event; Foundations; Funding; Goals; HIV; HIV Infections; Health; Individual; Intervention; Kidney; Knowledge; Life; Link; Liver; Longevity; Measurement; Mentors; Methodology; Mission; Modernization; Monoclonal Antibody R24; Nature; Network-based; Neurocognitive; North Carolina; Outcome; Pathogenesis; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Peer Review; Penetrance; Personal Satisfaction; Persons; Policies; Policy Maker; Randomized; Recording of previous events; Research; Research Personnel; Research Priority; Research Project Grants; Research Support; Resources; Sampling; Scientist; Secure; Site; Social Behavior; Source; Specimen; System; Testing; Training; Translational Research; Viral; Virus; Washington; Work; adjudication; analytical method; antiretroviral therapy; base; career; career development; clinical care; clinical epidemiology; clinically relevant; cohesion; cohort; comorbidity; comparative effectiveness; cost; cost effectiveness; data repository; distributed data; effective therapy; electronic data; epidemiologic data; epidemiology study; experience; improved; innovation; neoplastic; novel; novel therapeutics; pandemic disease; point of care; prevent; programs; repository; sample collection; success; virology

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.

在美国（US），尚未描述HIV感染者（PWH）中COVID-19（由SARS-CoV-2引起的疾病）的临床表现和严重程度。了解2019冠状病毒病在威尔斯亲王医院的各种表现及特定人群的风险因素至关重要。威尔斯亲王医院的免疫反应改变，可能会有更高的并发症和死亡风险。美国近一半的PWH年龄在50岁或以上，其中许多人患有多种合并症，包括糖尿病、高血压、心血管疾病（CVD）和B或C型肝炎病毒合并感染，每种疾病都可能增加严重COVID-19疾病和死亡的风险。拟议的研究将建立在强大的基础设施和研究平台的前瞻性收集和验证的数据在多站点CFAR网络的综合临床系统（CNICS）队列，以调查风险因素和临床表现的COVID-19在一个地理和人口统计学上多样化的人群PWH在美国各地的常规护理。这一补充将使我们能够迅速扩大CNICS数据收集（诊断、实验室、药物和程序数据）和病历审查程序，以确保相关临床因素（例如，伴随使用血管紧张素转换酶抑制剂和直接作用的抗病毒药物）、基线合并症、疾病严重程度指标（例如，院内事件呼吸、心脏、血栓、血液、炎症和肾脏后果）和COVID-19的结果，并对其进行判定，以表征在威尔斯亲王医院发生的实验室确认的COVID-19病例。我们将研究PWH中PCR阳性SARS-CoV-2感染的观察发病率、严重临床结局（住院、ICU入院、插管）的预测因素和死亡率。我们亦会利用从常规护理中获得的SARS-CoV-2血清学测试数据，估计威尔斯亲王对SARS-CoV-2有轻微症状或无症状血清转换的比例。我们的总体假设是，PWH中COVID-19疾病的严重程度将高于一般人群，特别是那些可检测到HIV病毒血症、低CD 4细胞计数和较高合并症负担（包括肥胖、糖尿病、CVD、肝脏和肺部疾病）的人群。该补充利用CNICS中可用的全面数据，并利用快速纳入新数据元素和裁定新临床结局的能力。