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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.

Timo B BrakenhoffBilly FranksBrianna Mae GoodaleJanneke van de WijgertSantiago MontesDuco VeenEskild K FredslundTheo RispensLorenz RischAriel V DowlingAmos A FolarinPatricia BruijningRichard DobsonTessa HeikampPaul KlaverMaureen CroninDiederick E Grobbeenull null
Published in: Trials (2021)
Protocol version: 1.2, dated January 22nd, 2021 Start of recruitment: February 22nd, 2021 End of recruitment (estimated): April 2021 End of follow-up (estimated): December 2021 TRIAL REGISTRATION: The trial has been registered at the Netherlands Trial Register on the 18th of February, 2021 with number NL9320 ( https://www.trialregister.nl/trial/9320 ) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Keyphrases
  • study protocol
  • sars cov
  • phase iii
  • randomized controlled trial
  • phase ii
  • clinical trial
  • open label
  • coronavirus disease
  • physical activity
  • placebo controlled
  • heart rate