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COVID-19 Surveillance Based on Smart Wearable Device (COVID-19SWD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459637
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Guangfa Wang, Peking University First Hospital

Brief Summary:
This is a prospective, multi-center cohort study. 200 subjects with COVID-19will be included . Wearable device's physiological parameters and clinical data will be continually collected , the investigators aim to explore whether using smart wearable devices is useful to early alerting deterioration of COVID-19.

Condition or disease
COVID-19

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Surveillance of COVID-19 Using Smart Wearable Devices: a Prospective Study
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : March 10, 2021

Group/Cohort
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)
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)
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)
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)
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)



Primary Outcome Measures :
  1. Deterioration of the condition [ Time Frame: 30 minutes ]

    Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)

    1. The development from asymptomatic to mild/general-type
    2. The development from mild to general-type/severe type
    3. The development from general-type to severe/critical type
    4. The development from severe to critical type


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 14days and/or 28days ]
    Mortality within 14days and 28days after admission

  2. The information analysis degree, the proportion of signal loss, the proportion of wrong signal, [ Time Frame: 30 minutes ]
    The information analysis degree, the proportion of signal loss, the proportion of wrong signal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)
Criteria

Inclusion Criteria:

  1. Age between 18 and 75 years(both 18 and 75), either gender;
  2. At the time of enrollment, patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh Edition)
  3. Able to engage in daily activities;
  4. Willing to participate in this research and willing to follow the research program, with the ability to sign informed consent;
  5. having mobile communication equipment which can install APP of wearable device.

Exclusion Criteria:

  1. Wear time of wearable devices <50% during the whole study period
  2. Wearable devices have faults, missing signals or errors throughout the study period, resulting in the proportion of analyzable information <50%
  3. Patients with incomplete outpatient and inpatient information and missing core information such as hospitalization / discharge time, symptoms, laboratory examination, disease progress record, etc.
  4. 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
  5. Unable to take care of themselves in daily life, unable to cooperate with medical history and data collection
  6. participating in other clinical trials;
  7. Pregnant women, women in puerperium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459637


Locations
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China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Contact: Guangfa Wang, MD.    13810644029    wangguangfa@hotmail.com   
Contact: Jiping Liao, PhD.    13521714181    colorfulwing01@163.com   
Sub-Investigator: Jing Ma         
Sub-Investigator: Hong Zhang         
Sub-Investigator: Cheng Zhang         
Sub-Investigator: Chunbo Zhang         
Sub-Investigator: Yunxia Wang         
Sub-Investigator: Fangfang Guo         
Sub-Investigator: Zhu Tian         
Sponsors and Collaborators
Peking University First Hospital
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Responsible Party: Guangfa Wang, Professor & MD., Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04459637    
Other Study ID Numbers: 2020055-0615
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangfa Wang, Peking University First Hospital:
COVID-19 Surveillance Smart wearable device