Mobile Health Study and Chemoprophylaxis for Preventing Severe Illness from COVID-19 in Cancer

预防癌症中因 COVID-19 引起的严重疾病的移动健康研究和化学预防

• 批准号: 10161019
• 负责人: ROBERT S. MANNEL
• 金额: $ 21.7万
• 依托单位: UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10161019
• 关键词: 2019-nCoV; Address; American Indians; Azithromycin; COVID-19; COVID-19 pandemic; Cancer Burden; Cancer Center; Cancer Center Support Grant; Cancer Patient; Case Study; Catchment Area; Cellular Phone; Cessation of life; Chemoprophylaxis; Chemotherapy-Oncologic Procedure; Clinic; Clinical; Clinical Trials; Collaborations; Detection; Deterioration; Development; Diagnosis; Disease; Disease Outbreaks; Education; Emergency Situation; Environment; Exposure to; Funding; Goals; Health Personnel; Health Professional; Hydroxychloroquine; Immunocompromised Host; Incidence; Infection; Intensive Care Units; Intervention; Lead; Leadership; Malignant Neoplasms; Mediating; Medical; Monitor; Morbidity - disease rate; NCI-Designated Cancer Center; Nature; Office Nursing; Oklahoma; Patient Self-Report; Patient-Focused Outcomes; Patients; Population; Prevention; Prophylactic treatment; Randomized; Reporting; Research; Research Personnel; Resource Sharing; Resources; Risk; Rural; SARS coronavirus; Secure; Services; Severity of illness; Source; Statutes and Laws; Structure; Supportive care; Symptoms; Telemedicine; Testing; Time; Training; Triage; United States; Universities; antimicrobial; attributable mortality; base; cancer care; cancer education; cancer health disparity; cancer prevention; care delivery; career; chemotherapy; coronavirus disease; high risk; high risk population; high standard; mHealth; mortality; multidisciplinary; next generation; novel coronavirus; patient home care; prevent; programs; response; screening; smartphone Application; standard of care; tool; treatment research; ventilation

The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) outbreak in late 2019 has resulted in approximately 1.4 million confirmed cases of novel coronavirus disease (COVID-19), with 85,522 confirmed deaths worldwide. The United States has recently taken the lead with the most reported cases across the world, with a total of 395,030 new cases and 12,740 attributable deaths as of today, April 9, 2020. Severe disease occurs in ~10% of cases overall. However, risk for severe disease and mortality is greater in immunocompromised cancer patients, requiring scarce ventilation resources and intensive care unit space to address rapid clinical deterioration in this population. We propose to use the established InsightTM mHealth Platform (supported by the Stephenson Cancer Center (SCC) mHealth Shared Resource) to monitor symptoms that are consistent with early signs of infection in this high-risk population and automatically (and securely) transfer this information to health care providers. Further, we aim to determine if antimicrobial prophylaxis can mitigate the severity of disease resulting from SARS-CoV-2 infection in cancer patients. Specific Aims: 1. Rapidly deploy a smartphone-based assessment and intervention tool that will enable actively treating cancer patients (N=500) to monitor and self-report symptoms and disease exposures in real-time. The InsightTM app will be downloaded onto the smartphones of patients undergoing cancer chemotherapy. Standard COVID-19 screening questions and a single chemotherapy risk question will be assessed daily through the smartphone app. Specific responses will automatically trigger an alert to clinic nurses AND provide app-based access to contact the clinic for triage to home care or emergency assessment. 2. Initiate antimicrobial prophylaxis in patients that indicate two symptoms or one symptom with exposure to COVID-19 in advance of or concomitant with SARS-CoV-2 testing. When emergent medical intervention is not required, patients will be randomized to standard supportive care or antimicrobial prophylaxis with hydroxychloroquine and azithromycin and will use the app to report daily changes in symptoms. 3. Collaboratively document and share lessons learned regarding the impact of the COVID-19 pandemic on cancer care delivery via telemedicine. We commit to a collegial collaboration with other cancer centers funded to study the use of telemedicine through the COVID-19 CCSG supplement mechanism. This study will determine if an app can be used to rapidly report SARS-CoV2 symptoms, and if antimicrobial prophylaxis reduces severe morbidity and mortality of SAR-CoV2 in immunocompromised cancer patients. The potential reduction of severe COVID-19 mediated disease through: 1) reducing time from symptom detection to treatment initiation, and 2) use of antimicrobial prophylaxis with the repurposed agents listed above. The mHealth platform will be used to monitor symptoms in real-time and facilitate medical triage of high-risk patients. Antimicrobial prophylaxis will further decrease the incidence of COVID-19 mediated morbidity and mortality.

2019年底，严重的急性呼吸道综合症病毒2（SARS-COV-2）暴发导致大约140万例确认的新型冠状病毒病例（Covid-19），全世界有85,522例确认死亡。美国最近在全球案件中占据领先地位，截至2020年4月9日，总共有395,030例新病例和12,740例可归因于死亡。然而，免疫功能低下的癌症患者的严重疾病和死亡率的风险更大，需要稀缺的通风资源和重症监护病房空间来解决该人群的快速临床恶化。我们建议使用已建立的InsightTM MHealth平台（由Stephenson癌症中心（SCC）MHealth共享资源支持）来监测与此高风险人群中早期感染迹象一致的症状，并自动（并安全地）将此信息转移到医疗保健提供者中。此外，我们旨在确定抗菌预防是否可以减轻癌症患者SARS-COV-2感染引起的疾病严重程度。具体目的：1。迅速部署基于智能手机的评估和干预工具，该工具将使癌症患者（n = 500）能够实时监测和自我报告症状和疾病暴露。 InsightTM应用程序将下载到接受癌症化疗的患者的智能手机上。标准COVID-19筛查问题和单一的化学疗法风险问题将每天通过智能手机应用程序进行评估。具体的答复将自动触发对诊所护士的警报，并提供基于应用程序的访问权限，联系诊所以进行家庭护理或紧急评估。 2。在患者中启动抗菌预防，表明两种症状或一种症状，并在与SARS-COV-2测试之前或与SARS-COV-2测试之前暴露于Covid-19。当不需要紧急医疗干预时，患者将通过羟基氯喹和阿奇霉素随机分配标准的支持性护理或抗菌预防，并将使用该应用程序报告症状的每日变化。 3.合作记录并分享有关Covid-19-19通过远程医疗提供癌症护理的影响的经验教训。我们致力于与资助通过COVID-19 CCSG补充机制研究远程医疗的其他癌症中心的合作合作。这项研究将确定应用程序是否可以快速报告SARS-COV2症状，以及抗菌预防是否会降低SAR-COV2在免疫功能低下的癌症患者中的严重发病率和死亡率。通过以下方式减少严重的COVID-19介导的疾病的潜在减少：1）从症状检测到治疗开始的时间，以及2）使用上面列出的重新塑造药物使用抗菌预防。 MHealth平台将用于实时监测症状，并促进高危患者的医疗分类。抗菌预防将进一步降低Covid-19介导的发病率和死亡率的发生率。