Zwiers, Laura CLaura CZwiersBrakenhoff, Timo BTimo BBrakenhoffGoodale, Brianna MBrianna MGoodaleVeen, DucoDucoVeenDownward, George SGeorge SDownwardKovacevic, VladimirVladimirKovacevicMarkovic, AndjelaAndjelaMarkovicMitratza, MariannaMariannaMitratzavan Willigen, MarcelMarcelvan WilligenFranks, BillyBillyFranksvan de Wijgert, JannekeJannekevan de WijgertMontes, SantiagoSantiagoMontesKorkmaz, SerkanSerkanKorkmazKjellberg, JakobJakobKjellbergRisch, LorenzLorenzRisch0000-0003-2692-6699Conen, DavidDavidConenRisch, MartinMartinRisch0000-0003-2692-6699Grossman, KirstenKirstenGrossmanWeideli, Ornella COrnella CWeideliRispens, TheoTheoRispensBouwman, JonJonBouwmanFolarin, Amos AAmos AFolarinBai, XiXiBaiDobson, RichardRichardDobsonCronin, MaureenMaureenCroninGrobbee, Diederick EDiederick EGrobbee2025-07-082025-07-082025https://boris-portal.unibe.ch/handle/20.500.12422/211823Background Rapid and early detection of SARS-CoV-2 infections, especially during the pre- or asymptomatic phase, could aid in reducing virus spread. Physiological parameters measured by wearable devices can be efficiently analysed to provide early detection of infections. The COVID-19 Remote Early Detection (COVID-RED) trial investigated the use of a wearable device (Ava bracelet) for improved early detection of SARS-CoV-2 infections in real-time.Trial Design Prospective, single-blinded, two-period, two-sequence, randomised controlled crossover trial.Methods Subjects wore a medical device and synced it with a mobile application in which they also reported symptoms. Subjects in the experimental condition received real-time infection indications based on an algorithm using both wearable device and self-reported symptom data, while subjects in the control arm received indications based on daily symptom-reporting only. Subjects were asked to get tested for SARS-CoV-2 when receiving an app-generated alert, and additionally underwent periodic SARS-CoV-2 serology testing. The overall and early detection performance of both algorithms was evaluated and compared using metrics such as sensitivity and specificity.Results A total of 17,825 subjects were randomised within the study. Subjects in the experimental condition received an alert significantly earlier than those in the control condition (median of 0 versus 7 days before a positive SARS-CoV-2 test). The experimental algorithm achieved high sensitivity (93.8-99.2%) but low specificity (0.8-4.2%) when detecting infections during a specified period, while the control algorithm achieved more moderate sensitivity (43.3-46.4%) and specificity (66.4-65.0%). When detecting infection on a given day, the experimental algorithm also achieved higher sensitivity compared to the control algorithm (45-52% versus 28-33%), but much lower specificity (38-50% versus 93-97%).Conclusions Our findings highlight the potential role of wearable devices in early detection of SARS-CoV-2. The experimental algorithm overestimated infections, but future iterations could finetune the algorithm to improve specificity and enable it to differentiate between respiratory illnesses.Trial Registration Netherlands Trial Register number NL9320.en500 - Science::540 - Chemistry600 - Technology::610 - Medicine & healtharticle10.48620/891864047199510.1371/journal.pone.0325116