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.

在美国艾滋病毒（PWH）的人（美国）尚未描述Covid-19的临床表现和严重程度，即SARS-COV-2引起的疾病，在美国（美国）尚未描述。了解Covid-19在PWH和人群特定危险因素中的Covid-19表现范围至关重要。 PWH的免疫反应改变了，可能面临较高的Covid-19并发症和死亡的风险。在美国，近一半的PWH年龄在50岁以上，其中许多受到多种合并症的影响，包括糖尿病，高血压，心血管疾病（CVD）和乙型肝炎或C病毒连接，每种病毒也可能增加严重的Covid-19疾病和死亡的风险。拟议的研究将建立在综合临床系统（CNICS）同时多站点CFAR网络中的前瞻性基础设施和研究平台的基础上，以研究Covid-19的危险因素和临床表现，并在美国常规护理中的PWH上的地理和人口统计学多样化。 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,捕获和裁定Covid-19的血液学，炎症和肾脏后果）以及COVID-19的结果，以表征PWH中发生的实验室确认的COVID-19病例。我们将研究观察到的发病率，严重临床结果的预测因子（住院，ICU入院，插管）以及与PCR阳性SARS-COV-2感染相关的死亡率。使用通过常规护理获得的SARS-COV-2血清学测试数据，我们还将估计对SARS-COV-2具有最小症状或无症状的血清转化的PWH的比例。我们的总体假设是，PWH的Covid-19疾病的严重程度将比普通人群高，特别是在患有HIV病毒血症，低CD4细胞计数以及更高合并症负担（包括肥胖，糖尿病，CVD，CVD，肝脏和肝病）的人群中。这种补充利用了CNIC中可用的全面数据，并利用了快速纳入新的数据元素并裁定新型临床结果的能力。