Xofluza-Wearables Feasibility-Study

Summary

The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smart wearable device algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients.

Timeline

Start

2023-12-14

Primary completion

2025-04-30

Completion

2025-04-30

Publications

• Background Baxter D. Evaluating the case for trivalent or quadrivalent influenza vaccines. Hum Vaccin Immunother. 2016 Oct 2;12(10):2712-2717. doi: 10.1080/21645515.2015.1091130. Epub 2016 Jul 19.
• Background Vanderlinden E, Naesens L. Emerging antiviral strategies to interfere with influenza virus entry. Med Res Rev. 2014 Mar;34(2):301-39. doi: 10.1002/med.21289. Epub 2013 Jun 25.
• Background Tsang TK, Lau LLH, Cauchemez S, Cowling BJ. Household Transmission of Influenza Virus. Trends Microbiol. 2016 Feb;24(2):123-133. doi: 10.1016/j.tim.2015.10.012. Epub 2015 Nov 21.
• Background Paules C, Subbarao K. Influenza. Lancet. 2017 Aug 12;390(10095):697-708. doi: 10.1016/S0140-6736(17)30129-0. Epub 2017 Mar 13.
• Background Lee N, Ison MG. Diagnosis, management and outcomes of adults hospitalized with influenza. Antivir Ther. 2012;17(1 Pt B):143-57. doi: 10.3851/IMP2059. Epub 2012 Feb 3.
• Background Kumar D, Michaels MG, Morris MI, Green M, Avery RK, Liu C, Danziger-Isakov L, Stosor V, Estabrook M, Gantt S, Marr KA, Martin S, Silveira FP, Razonable RR, Allen UD, Levi ME, Lyon GM, Bell LE, Huprikar S, Patel G, Gregg KS, Pursell K, Helmersen D, Julian KG, Shiley K, Bono B, Dharnidharka VR, Alavi G, Kalpoe JS, Shoham S, Reid GE, Humar A; American Society of Transplantation H1N1 Collaborative Study Group. Outcomes from pandemic influenza A H1N1 infection in recipients of solid-organ transplants: a multicentre cohort study. Lancet Infect Dis. 2010 Aug;10(8):521-6. doi: 10.1016/S1473-3099(10)70133-X. Epub 2010 Jul 9.
• Background Kumar D, Ferreira VH, Blumberg E, Silveira F, Cordero E, Perez-Romero P, Aydillo T, Danziger-Isakov L, Limaye AP, Carratala J, Munoz P, Montejo M, Lopez-Medrano F, Farinas MC, Gavalda J, Moreno A, Levi M, Fortun J, Torre-Cisneros J, Englund JA, Natori Y, Husain S, Reid G, Sharma TS, Humar A. A 5-Year Prospective Multicenter Evaluation of Influenza Infection in Transplant Recipients. Clin Infect Dis. 2018 Oct 15;67(9):1322-1329. doi: 10.1093/cid/ciy294.
• Background Noshi T, Kitano M, Taniguchi K, Yamamoto A, Omoto S, Baba K, Hashimoto T, Ishida K, Kushima Y, Hattori K, Kawai M, Yoshida R, Kobayashi M, Yoshinaga T, Sato A, Okamatsu M, Sakoda Y, Kida H, Shishido T, Naito A. In vitro characterization of baloxavir acid, a first-in-class cap-dependent endonuclease inhibitor of the influenza virus polymerase PA subunit. Antiviral Res. 2018 Dec;160:109-117. doi: 10.1016/j.antiviral.2018.10.008. Epub 2018 Oct 11.
• Background O'Hanlon R, Shaw ML. Baloxavir marboxil: the new influenza drug on the market. Curr Opin Virol. 2019 Apr;35:14-18. doi: 10.1016/j.coviro.2019.01.006. Epub 2019 Mar 8.
• Background Watanabe A, Ishida T, Hirotsu N, Kawaguchi K, Ishibashi T, Shishido T, Sato C, Portsmouth S, Tsuchiya K, Uehara T. Baloxavir marboxil in Japanese patients with seasonal influenza: Dose response and virus type/subtype outcomes from a randomized phase 2 study. Antiviral Res. 2019 Mar;163:75-81. doi: 10.1016/j.antiviral.2019.01.012. Epub 2019 Jan 23.
• Background Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.
• Background Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9. Epub 2020 Jun 8.
• Background Baker J, Block SL, Matharu B, Burleigh Macutkiewicz L, Wildum S, Dimonaco S, Collinson N, Clinch B, Piedra PA. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children: A Randomized, Double-blind, Active Controlled Phase 3 Safety and Efficacy Trial (miniSTONE-2). Pediatr Infect Dis J. 2020 Aug;39(8):700-705. doi: 10.1097/INF.0000000000002747.
• Background Ikematsu H, Hayden FG, Kawaguchi K, Kinoshita M, de Jong MD, Lee N, Takashima S, Noshi T, Tsuchiya K, Uehara T. Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts. N Engl J Med. 2020 Jul 23;383(4):309-320. doi: 10.1056/NEJMoa1915341. Epub 2020 Jul 8.
• Background Umemura T, Mutoh Y, Kawamura T, Saito M, Mizuno T, Ota A, Kozaki K, Yamada T, Ikeda Y, Ichihara T. Efficacy of baloxavir marboxil on household transmission of influenza infection. J Pharm Health Care Sci. 2020 Oct 1;6:21. doi: 10.1186/s40780-020-00178-4. eCollection 2020.
• Background Shirley M. Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza. Drugs. 2020 Jul;80(11):1109-1118. doi: 10.1007/s40265-020-01350-8.
• Background Neuberger E, Wallick C, Chawla D, Castro RC. Baloxavir vs oseltamivir: reduced utilization and costs in influenza. Am J Manag Care. 2022 Mar 1;28(3):e88-e95. doi: 10.37765/ajmc.2022.88786.
• Background Alavi A, Bogu GK, Wang M, Rangan ES, Brooks AW, Wang Q, Higgs E, Celli A, Mishra T, Metwally AA, Cha K, Knowles P, Alavi AA, Bhasin R, Panchamukhi S, Celis D, Aditya T, Honkala A, Rolnik B, Hunting E, Dagan-Rosenfeld O, Chauhan A, Li JW, Bejikian C, Krishnan V, McGuire L, Li X, Bahmani A, Snyder MP. Real-time alerting system for COVID-19 and other stress events using wearable data. Nat Med. 2022 Jan;28(1):175-184. doi: 10.1038/s41591-021-01593-2. Epub 2021 Nov 29.
• Background Keating BJ, Mukhtar EH, Elftmann ED, Eweje FR, Gao H, Ibrahim LI, Kathawate RG, Lee AC, Li EH, Moore KA, Nair N, Chaluvadi V, Reason J, Zanoni F, Honkala AT, Al-Ali AK, Abdullah Alrubaish F, Ahmad Al-Mozaini M, Al-Muhanna FA, Al-Romaih K, Goldfarb SB, Kellogg R, Kiryluk K, Kizilbash SJ, Kohut TJ, Kumar J, O'Connor MJ, Rand EB, Redfield RR, Rolnik B, Rossano J, Sanchez PG, Alavi A, Bahmani A, Bogu GK, Brooks AW, Metwally AA, Mishra T, Marks SD, Montgomery RA, Fishman JA, Amaral S, Jacobson PA, Wang M, Snyder MP. Early detection of SARS-CoV-2 and other infections in solid organ transplant recipients and household members using wearable devices. Transpl Int. 2021 Jun;34(6):1019-1031. doi: 10.1111/tri.13860. Epub 2021 May 5.
• Background Mishra T, Wang M, Metwally AA, Bogu GK, Brooks AW, Bahmani A, Alavi A, Celli A, Higgs E, Dagan-Rosenfeld O, Fay B, Kirkpatrick S, Kellogg R, Gibson M, Wang T, Hunting EM, Mamic P, Ganz AB, Rolnik B, Li X, Snyder MP. Pre-symptomatic detection of COVID-19 from smartwatch data. Nat Biomed Eng. 2020 Dec;4(12):1208-1220. doi: 10.1038/s41551-020-00640-6. Epub 2020 Nov 18.
• Background Grzesiak E, Bent B, McClain MT, Woods CW, Tsalik EL, Nicholson BP, Veldman T, Burke TW, Gardener Z, Bergstrom E, Turner RB, Chiu C, Doraiswamy PM, Hero A, Henao R, Ginsburg GS, Dunn J. Assessment of the Feasibility of Using Noninvasive Wearable Biometric Monitoring Sensors to Detect Influenza and the Common Cold Before Symptom Onset. JAMA Netw Open. 2021 Sep 1;4(9):e2128534. doi: 10.1001/jamanetworkopen.2021.28534.
• Background Vilchez RA, McCurry K, Dauber J, Lacono A, Griffith B, Fung J, Kusne S. Influenza virus infection in adult solid organ transplant recipients. Am J Transplant. 2002 Mar;2(3):287-91. doi: 10.1034/j.1600-6143.2002.20315.x.
• Background Marois C, Nedelec T, Pelle J, Rozes A, Durrleman S, Dufouil C, Demoule A. Comparison of Clinical Profiles and Mortality Outcomes Between Influenza and COVID-19 Patients Invasively Ventilated in the ICU: A Retrospective Study From All Paris Public Hospitals From 2016 to 2021. Crit Care Explor. 2022 Jul 25;4(7):e0737. doi: 10.1097/CCE.0000000000000737. eCollection 2022 Jul.
• Background Helantera I, Gissler M, Rimhanen-Finne R, Ikonen N, Kanerva M, Lempinen M, Finne P. Epidemiology of laboratory-confirmed influenza among kidney transplant recipients compared to the general population-A nationwide cohort study. Am J Transplant. 2021 May;21(5):1848-1856. doi: 10.1111/ajt.16421. Epub 2021 Feb 19.
• Background Mombelli M, Kampouri E, Manuel O. Influenza in solid organ transplant recipients: epidemiology, management, and outcomes. Expert Rev Anti Infect Ther. 2020 Feb;18(2):103-112. doi: 10.1080/14787210.2020.1713098. Epub 2020 Jan 18.
• Background Kuchipudi SV, Behring D, Nissly R, Chothe SK, Gontu A, Ravichandran A, Butler T. Mitigating the Impact of Emerging Animal Infectious Disease Threats: First Emerging Animal Infectious Diseases Conference (EAIDC) Report. Viruses. 2022 Apr 30;14(5):947. doi: 10.3390/v14050947.

Drugs

Indications