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Continuous vital signs monitoring in healthy volunteers undergoing a COVID-19 challenge trial

The virtual High Dependency Unit (vHDU) Challenge study: continuous vital signs monitoring in COVID-19 challenge participants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14105049
Enrollment
45
Registered
2022-09-16
Start date
2022-09-20
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

The study will be conducted in the Clinical Research Facility at the Churchill Hospital in Oxford. The COV-CHIM01 trial participants (also the study population) are admitted 2 days prior to exposure t

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 02/08/2024: 1. Participation in the COV-CHIM01/COV-HIC001/COV-CHIM02 study 2. Participant is willing and able to give informed consent for participation in this study 3. Aged 18 years or over _____ Previous inclusion criteria: 1. Participation in the COV-CHIM01 study 2. Participant is willing and able to give informed consent for participation in this study 3. Aged 18 years or over

Exclusion criteria

Exclusion criteria: 1. Intra-cardiac device 2. Known history of cardiac arrhythmias 3. Allergy to adhesives

Design outcomes

Primary

MeasureTime frame
The feasibility of early detection of COVID-19 infection using data collected by wearable devices and the measured variation in vital signs from continuous monitoring during the course of the study (up to Day 12)

Secondary

MeasureTime frame
1. Demographic data collected using a questionnaire at the start of the study 2. Wearability measured using a questionnaire on Day 6 of the study 3. Heart rate, respiratory rate, blood pressure, oxygen saturation, temperature data and infection data collected by the COV-CHIM01 study team at regular intervals based on Challenge protocol 4. Accelerometer data, heart rate and respiratory rate variability data from the wearable device (VitalPatch) monitored continuously during the course of the study (up to Day 12)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026