- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459637
COVID-19 Surveillance Based on Smart Wearable Device (COVID-19SWD)
Surveillance of COVID-19 Using Smart Wearable Devices: a Prospective Study
Study Overview
Status
Conditions
Detailed Description
This is a prospective cohort study. 200 subjects aged 18~75y with asymptomatic, mild, general-type COVID-19 will be recruited. The physiological parameters of wearable devices, including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records, will be continuously collected from the day of admission / isolation to 14 days after discharge or out of quarantine. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. All clinical data of patients during hospitalization will be collected including demographic characteristics, onset time, visit time, hospitalization time, symptoms, physical examination, laboratory examination, imaging characteristics, disease severity, treatment and outcome. Primary outcome is the deterioration of disease, the correlation analysis between the change of wearable device physiological parameters and the deterioration of disease determined by the traditional disease evaluation system will be used to find it whether can early alert deterioration of COVID-19.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2020-055). Any protocol modifications will be submitted for the IRB review and approval.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 18 and 75 years(both 18 and 75), either gender;
- At the time of enrollment, patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)
- Able to engage in daily activities;
- Willing to participate in this research and willing to follow the research program, with the ability to sign informed consent;
- having mobile communication equipment which can install APP of wearable device.
Exclusion Criteria:
- Wear time of wearable devices <50% during the whole study period
- Wearable devices have faults, missing signals or errors throughout the study period, resulting in the proportion of analyzable information <50%
- Patients with incomplete outpatient and inpatient information and missing core information such as hospitalization / discharge time, symptoms, laboratory examination, disease progress record, etc.
- Patients with serious underlying diseases (including serious mental diseases, mental disorders, nervous system diseases, malignant tumors, chronic liver diseases, heart failure, autoimmune diseases, chronic kidney diseases), or life expectancy less than 6 months
- Unable to take care of themselves in daily life, unable to cooperate with medical history and data collection
- participating in other clinical trials;
- Pregnant women, women in puerperium
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Asymptomatic group
Definition of asymptomatic disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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Mild group
Definition of mild disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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general-type group
Definition of general-type disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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severe group
Definition of severe disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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critical group
Definition of critical disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deterioration of the condition
Time Frame: 30 minutes
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Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
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30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 14days and/or 28days
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Mortality within 14days and 28days after admission
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14days and/or 28days
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The information analysis degree, the proportion of signal loss, the proportion of wrong signal,
Time Frame: 30 minutes
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The information analysis degree, the proportion of signal loss, the proportion of wrong signal
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30 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020055-0615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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