Real-world impact of the COVID-19 pandemic in people with multiple sclerosis

COVID-19 大流行对多发性硬化症患者的现实影响

• 批准号: 10549757
• 负责人: Zongqi Xia
• 金额: $ 39.84万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10549757
• 关键词: Address; Adverse reactions; Award; B-Lymphocytes; COVID-19; COVID-19 pandemic; COVID-19 pandemic effects; COVID-19 risk; COVID-19 severity; COVID-19 vaccine; Caring; Clinic; Clinical Management; Clinical Research; Collaborations; Complement; Data; Data Reporting; Data Set; Disease; Electronic Health Record; Enrollment; Exclusion; General Population; Health; Healthcare Systems; Infrastructure; Interferon-beta; Knowledge; Length of Stay; Low Prevalence; Mission; National Institute of Neurological Disorders and Stroke; Nervous System Physiology; Neurologic; Neurological outcome; Outcome; Participant; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Phase; Physicians; Publishing; Registries; Reporting; Research; Research Activity; Research Infrastructure; Rest; SARS-CoV-2 infection; Severities; Social Network; Surveys; Testing; Time; United States National Institutes of Health; Vaccinated; Vaccination; Vaccinee; Work; clinically relevant; cohort; coronavirus disease; data warehouse; disability; immunoregulation; multiple sclerosis patient; nervous system disorder; pandemic disease; pandemic impact; pre-pandemic; reduce symptoms; resilience; social; unvaccinated; vaccination outcome; vaccine efficacy; vaccine safety; vaccine trial; virtual

PROJECT SUMMARY AND ABSTRACT. The COVID-19 pandemic due to the SARS-CoV-2 infection poses new challenges to the ~3 million persons with multiple sclerosis (PwMS) worldwide. Major knowledge gaps include the extent to which common MS disease modifying therapies (DMTs) modulate the COVID-19 risk and severity, the efficacy of the COVID-19 vaccines and any impact on MS neurological outcomes given the exclusion of PwMS from COVID-19 vaccine trials, and the broader consequence of the pandemic on social connection and health outcomes in PwMS. These gaps create a critical need to rapidly generate rigorous information with which to guide clinical management. To address these challenges, we created the MSReCOV (MS Resilience to COVID-19) Collaborative in late March 2020 by assembling a network of MS Centers to leverage existing clinical research infrastructure and collect patient-reported data. Given the reduced interaction between PwMS and healthcare systems and the restriction on in-person research activities at the onset and during subsequent phases, we rapidly deployed online survey studies to gather real-time data directly from PwMS during the pandemic to complement the effort of physician-reported registries. To complement MSReCOV, we will interrogate the Optum data warehouse of integrated claims and electronic health records data from a virtual cohort of ~40,000 commercially insured PwMS (per year). Building on the MSReCOV and Optum infrastructure, we propose the following aims to address the knowledge gaps. Aim 1: Examine the association between MS DMTs and COVID-19. We will test the hypothesis that certain DMTs such as IFNb are associated with reduced COVID- 19 risk, while others such as B-cell depleting agents are associated with increased COVID-19 risk. Aim 2: Examine the COVID-19 vaccine efficacy and safety in MS and association with MS outcomes. We will first test the hypothesis that COVID-19 vaccines are effective and safe in PwMS and do not worsen clinically relevant patient-reported outcomes (PROs) of neurological function, and secondarily test the hypothesis that B- cell depleting treatments reduce vaccine efficacy whereas other DMTs do not. Aim 3: Examine the effect of the pandemic on personal social network and MS outcomes in PwMS. Building on our prior works, we will test the hypothesis that the pandemic (independent of the SARS-CoV-2 infection) negatively influences the neurological function in PwMS by altering personal social connection. Given the extent of the COVID-19 pandemic, real-world evidence emerging from the proposed study will critically inform the clinical management of PwMS during the rapidly changing landscape of neurological care. The project is highly relevant to the mission of the NIH/NINDS to reduce the burden of neurological diseases such as MS in the setting of the pandemic.

项目摘要和摘要。 SARS-CoV-2 感染引起的 COVID-19 大流行给约 300 万人带来了新的挑战 全球范围内患有多发性硬化症 (PwMS)。主要的知识差距包括常见 MS 的程度 疾病修饰疗法 (DMT) 可调节 COVID-19 的风险和严重程度以及 COVID-19 的功效 疫苗以及将 PwMS 排除在 COVID-19 疫苗之外对 MS 神经系统结果的任何影响 试验，以及大流行对 PwMS 的社会联系和健康结果的更广泛影响。 这些差距迫切需要快速生成严格的信息来指导临床 管理。为了应对这些挑战，我们创建了 MSReCOV（MS 对 COVID-19 的恢复能力） 于 2020 年 3 月下旬进行合作，组建 MS 中心网络以利用现有的临床研究 基础设施并收集患者报告的数据。鉴于 PwMS 和医疗保健之间的互动减少 系统以及在开始和后续阶段对亲自研究活动的限制，我们 快速部署在线调查研究，在大流行期间直接从 PwMS 收集实时数据， 补充医生报告的登记工作。为了补充 MSReCOV，我们将询问 Optum 数据仓库，包含来自约 40,000 人的虚拟队列的综合索赔和电子健康记录数据 商业保险 PwMS（每年）。基于 MSReCOV 和 Optum 基础设施，我们提出 以下旨在解决知识差距。目标 1：检查 MS DMT 和 新冠肺炎。我们将检验以下假设：某些 DMT（例如 IFNb）与减少新冠病毒感染有关 19 风险，而 B 细胞耗竭剂等其他药物则与 COVID-19 风险增加相关。目标 2： 检查 COVID-19 疫苗在多发性硬化症中的功效和安全性以及与多发性硬化症结果的关联。我们将 首先检验以下假设：COVID-19 疫苗在 PwMS 中有效且安全，并且临床上不会恶化 神经功能的相关患者报告结果（PRO），并其次检验 B- 细胞耗竭治疗会降低疫苗功效，而其他 DMT 则不会。目标 3：检查效果 个人社交网络的流行病和 PwMS 中的 MS 结果。在我们之前工作的基础上，我们将 检验这一假设：大流行（独立于 SARS-CoV-2 感染）对 通过改变个人社会联系来发挥 PwMS 的神经功能。鉴于 COVID-19 的严重程度 大流行期间，拟议研究中出现的真实世界证据将为临床管理提供重要信息 在快速变化的神经科护理领域中 PwMS 的应用。该项目与该项目高度相关 NIH/NINDS 的使命是减轻 MS 等神经系统疾病的负担 大流行。