Remote Early Detection of SARS-CoV-2 infections
- Conditions
- COVID-19
- Registration Number
- NL-OMON23180
- Lead Sponsor
- niversitair Medisch Centrum Utrecht (UMCU), Julius Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20000
•Resident of the Netherlands
•At least 18 years old
•Informed consent provided (electronic)
•Willing to adhere to the study procedures described in this protocol
•Must have a smartphone that runs at least Android 8.0 or iOS 13.0 operating systems and is active for the duration of the study (in the case of a change of mobile number, study team should be notified)
•Be able to read, understand and write Dutch
•Previous positive SARS-CoV-2 test result (confirmed either through PCR/antigen or antibody tests) (self-reported)
•Previously received a vaccine developed specifically for COVID-19 or in possession of an appointment for vaccination in the near future
•Current suspected (e.g. waiting for test result) coronavirus infection or symptoms of a coronavirus infection (self-reported)
•Participating in any other COVID-19 clinical drug, vaccine, or medical device trial
•Electronic implanted device (such as a pacemaker)
•Pregnant at time of informed consent (self-reported)
•Suffering from cholinergic urticaria (per the Ava bracelet’s User Manual)
•Staff involved in the management or conduct of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SARS-CoV-2 infection (as confirmed through a positive PCR/antigen or serology test)
- Secondary Outcome Measures
Name Time Method 1. Baseline demographic and risk factors (collected using an online form at subject registration)<br>2. Epidemiological and infection risk information (collected using bi-weekly online surveys)<br>3. Self-reported data on time to testing, testing procedures and the results (collected using bi-weekly online surveys)<br>4. Self-reported data on reception of COVID-19 vaccination (collected using bi-weekly online surveys)<br>5. Medical event reporting by subjects who have interactions with a general practitioner or a hospital related to SARS-CoV-2 infection, providing healthcare utilization measures during follow-up (collected using bi-weekly online surveys and followed-up by structured phone interviews)<br>6. Adverse device effects reporting by subjects (collected using bi-weekly online surveys and followed-up by structured phone interviews)