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

基本信息

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
项目类别：
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

项目摘要

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，严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 爆发，导致全球约 140 万例新型冠状病毒病 (COVID-19) 确诊病例，其中 85,522 例死亡。美国最近成为全球报告病例最多的国家，截至 2020 年 4 月 9 日，共有 395,030 例新病例和 12,740 例死亡病例。重症病例约占总体病例的 10%。然而，免疫功能低下的癌症患者发生严重疾病和死亡的风险更大，需要稀缺的通气资源和重症监护病房空间来解决该人群临床快速恶化的问题。我们建议使用已建立的 InsightTM 移动医疗平台（由史蒂芬森癌症中心 (SCC) 移动医疗共享资源支持）来监测与高危人群中感染早期迹象相符的症状，并自动（安全地）将此信息传输至医疗保健提供者。此外，我们的目标是确定抗菌药物预防是否可以减轻癌症患者 SARS-CoV-2 感染引起的疾病的严重程度。具体目标： 1. 快速部署基于智能手机的评估和干预工具，使积极治疗的癌症患者 (N=500) 能够实时监测和自我报告症状和疾病暴露情况。 InsightTM应用程序将被下载到接受癌症化疗的患者的智能手机上。标准的 COVID-19 筛查问题和单个化疗风险问题将每天通过智能手机应用程序进行评估。具体响应将自动向诊所护士触发警报，并提供基于应用程序的访问权限，以联系诊所进行家庭护理或紧急评估的分类。 2. 在 SARS-CoV-2 检测之前或同时，对出现两种症状或一种症状且暴露于 COVID-19 的患者开始抗菌药物预防。当不需要紧急医疗干预时，患者将被随机分配接受标准支持治疗或使用羟氯喹和阿奇霉素进行抗菌预防，并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 大流行对通过远程医疗提供癌症护理的影响的经验教训。我们致力于与其他受资助的癌症中心进行合作，通过 COVID-19 CCSG 补充机制研究远程医疗的使用。这项研究将确定应用程序是否可用于快速报告 SARS-CoV2 症状，以及抗菌药物预防是否可以降低免疫功能低下的癌症患者中 SAR-CoV2 的严重发病率和死亡率。通过以下方式可能减少严重的 COVID-19 介导的疾病：1) 缩短从症状检测到开始治疗的时间，2) 使用上述重新调整用途的药物进行抗菌预防。 mHealth平台将用于实时监测症状并促进高危患者的医疗分诊。抗菌预防将进一步降低 COVID-19 介导的发病率和死亡率。