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

2019年底爆发的严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）疫情已导致全球约140万例新型冠状病毒病（COVID-19）确诊病例，确诊死亡85,522例。美国最近在全球范围内报告的病例最多，截至2020年4月9日，美国共有395030例新发病例和12740例可归因死亡。严重疾病发生率约占总病例的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应对这一人群的快速临床恶化。我们建议使用已建立的InsightTM移动健康平台（由斯蒂芬森癌症中心（SCC）移动健康共享资源支持）来监测高危人群中与早期感染迹象一致的症状，并自动（且安全地）将此信息传输给医疗保健提供者。此外，我们的目的是确定抗菌素预防是否可以减轻癌症患者因SARS-CoV-2感染而导致的疾病严重程度。具体目标：1；快速部署基于智能手机的评估和干预工具，使积极治疗癌症患者（N=500）能够实时监测和自我报告症状和疾病暴露。insightm应用程序将下载到正在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。具体的回答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，以联系诊所，以便进行家庭护理或紧急评估。2. 在进行SARS-CoV-2检测之前或同时暴露于COVID-19的患者出现两种或一种症状时，应启动抗菌素预防治疗。当不需要紧急医疗干预时，患者将随机接受标准支持治疗或羟氯喹和阿奇霉素的抗菌预防治疗，并使用该应用程序报告每日症状变化。3. 协作记录和分享有关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。我们承诺与其他资助的癌症中心合作，通过COVID-19 CCSG补充机制研究远程医疗的使用。这项研究将确定一款应用程序是否可以用于快速报告SARS-CoV2症状，以及抗菌预防是否可以降低免疫功能低下的癌症患者中SARS-CoV2的严重发病率和死亡率。通过以下途径可能减少COVID-19介导的严重疾病：1)缩短从发现症状到开始治疗的时间，以及2)使用上述重新使用的药物进行抗菌预防。移动医疗平台将用于实时监测症状，并促进高风险患者的医疗分诊。抗菌素预防将进一步降低COVID-19介导的发病率和死亡率。

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.