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

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 3P30CA225520-03S3

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2018
    2023
  • Known Financial Commitments (USD)

    $217,000
  • Funder

    National Institutes of Health (NIH)
  • Principal Investigator

    Robert S Mannel
  • Research Location

    United States of America
  • Lead Research Institution

    University Of Oklahoma Hlth Sciences Ctr
  • Research Priority Alignment

    N/A
  • Research Category

    Clinical characterisation and management

  • Research Subcategory

    Disease pathogenesis

  • Special Interest Tags

    Digital Health

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Other

  • Occupations of Interest

    Unspecified

Abstract

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.