Evidence map›Paper›PMID 40471995›Full record

Trial reportPloS one2025

Remote early detection of SARS-CoV-2 infections using a wearable-based algorithm: Results from the COVID-RED study, a prospective randomised single-blinded crossover trial.

Laura C Zwiers, Timo B Brakenhoff, Brianna M Goodale, Duco Veen, George S Downward, Vladimir Kovacevic, Andjela Markovic, Marianna Mitratza, Marcel van Willigen, Billy Franks and 17 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Digital medicine for infectious diseases.Nature communications · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Laura C ZwiersJulius Clinical, Zeist, The Netherlands.ORCID https://orcid.org/0009-0000-4080-6541
Timo B BrakenhoffJulius Clinical, Zeist, The Netherlands.ORCID https://orcid.org/0000-0003-3543-6296
Brianna M GoodaleJulius Clinical, Zeist, The Netherlands.
Duco VeenDepartment of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0002-8352-7574
George S DownwardDepartment of Global Health and Bioethics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Vladimir KovacevicAva AG, Zürich, Switzerland.ORCID https://orcid.org/0000-0002-9843-6261
Andjela MarkovicAva AG, Zürich, Switzerland.ORCID https://orcid.org/0000-0003-2104-9543
Marianna MitratzaDepartment of Global Health and Bioethics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Marcel van WilligenJulius Clinical, Zeist, The Netherlands.ORCID https://orcid.org/0000-0003-3510-7564
Billy FranksJulius Clinical, Zeist, The Netherlands.ORCID https://orcid.org/0000-0002-1137-8792
Janneke van de WijgertDepartment of Epidemiology and Health Economics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0003-2728-4560
Santiago MontesRoche Diagnostics Nederland B.V., Almere, The Netherlands.
Serkan KorkmazVIVE, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-5052-0982
Jakob KjellbergVIVE, Copenhagen, Denmark.
Lorenz RischLaboratory Dr. Risch, Vaduz, Liechtenstein.
David ConenPopulation Health Research Institute, McMaster University, Hamilton, Canada.ORCID https://orcid.org/0000-0002-2459-5251
Martin RischLaboratory Dr. Risch, Vaduz, Liechtenstein.
Kirsten GrossmanLaboratory Dr. Risch, Vaduz, Liechtenstein.ORCID https://orcid.org/0000-0002-0460-3736
Ornella C WeideliLaboratory Dr. Risch, Vaduz, Liechtenstein.
Theo RispensSanquin Research and Landsteiner Laboratory, Amsterdam UMC, Amsterdam, The Netherlands.
Jon BouwmanJulius Clinical, Zeist, The Netherlands.
Amos A FolarinInstitute of Health Informatics, University College London, London, United Kingdom.
Xi BaiInstitute of Health Informatics, University College London, London, United Kingdom.
Richard DobsonInstitute of Health Informatics, University College London, London, United Kingdom.
Maureen CroninAva AG, Zürich, Switzerland.
Diederick E GrobbeeJulius Clinical, Zeist, The Netherlands.
COVID-RED consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRapid 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

designProspective, single-blinded, two-period, two-sequence, randomised controlled crossover trial.

methodsSubjects 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.

resultsA 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%).

conclusionsOur 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 registrationNetherlands Trial Register number NL9320.

Indexed as

AlgorithmsCOVID-19Wearable Electronic DevicesAdultAgedCross-Over StudiesEarly DiagnosisFemaleHumansMaleMiddle AgedMobile ApplicationsProspective StudiesSARS-CoV-2Single-Blind Method

Identifiers

PMID40471995
PMCPMC12140236

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.