Abstract
A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial
Highlights
It is currently thought that most—but not all—individuals infected with SARS-CoV-2 develop symptoms, but that the infectious period starts on average two days before the first overt symptoms appear
It is estimated that pre- and asymptomatic individuals are responsible for more than half of all transmissions
Previous positive SARS-CoV-2 test result Previously received a vaccine developed for COVID-19 or in possession of an appointment for vaccination in the near future Current suspected COVID-19 infection or symptoms of a COVID-19 infection Participating in any other COVID-19 clinical drug, vaccine, or medical device trial Electronic implanted device Pregnant at time of informed consent Suffering from cholinergic urticaria Staff involved in the management or conduct of this study (Continued on page)
Summary
Brakenhoff et al Trials (2021) 22:412 (Continued from previous page) the algorithm using self-reported Daily Symptom Diary data alone (Symptom Only Algo; control condition) Previous positive SARS-CoV-2 test result (confirmed either through PCR/antigen or antibody tests; self-reported) Previously received a vaccine developed for COVID-19 or in possession of an appointment for vaccination in the near future (self-reported) Current suspected (e.g., waiting for test result) COVID-19 infection or symptoms of a COVID-19 infection (selfreported) Participating in any other COVID-19 clinical drug, vaccine, or medical device trial (self-reported) Electronic implanted device (such as a pacemaker; self-reported) Pregnant at time of informed consent (self-reported) Suffering from cholinergic urticaria (per the Ava bracelet’s User Manual; self-reported) Staff involved in the management or conduct of this study (Continued on page)
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