Remote Early Detection of SARS-CoV-2 infections

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23180

Enrollment

20000

Registered

2021-02-18

Start date

2021-02-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Ava COVID-RED app and the Ava bracelet

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
SARS-CoV-2 infection (as confirmed through a positive PCR/antigen or serology test)	—

Secondary

Measure	Time frame
1. Baseline demographic and risk factors (collected using an online form at subject registration) 2. Epidemiological and infection risk information (collected using bi-weekly online surveys) 3. Self-reported data on time to testing, testing procedures and the results (collected using bi-weekly online surveys) 4. Self-reported data on reception of COVID-19 vaccination (collected using bi-weekly online surveys) 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) 6. Adverse device effects reporting by subjects (collected using bi-weekly online surveys and followed-up by structured phone interviews)	—

Measure

Time frame

1. Baseline demographic and risk factors (collected using an online form at subject registration) 2. Epidemiological and infection risk information (collected using bi-weekly online surveys) 3. Self-reported data on time to testing, testing procedures and the results (collected using bi-weekly online surveys) 4. Self-reported data on reception of COVID-19 vaccination (collected using bi-weekly online surveys) 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) 6. Adverse device effects reporting by subjects (collected using bi-weekly online surveys and followed-up by structured phone interviews)

—

Contacts

Public ContactPieter Stolk

UMCU Utrecht

p.stolk@umcutrecht.nl+31624214271

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)