<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459637</url>
  </required_header>
  <id_info>
    <org_study_id>2020055-0615</org_study_id>
    <nct_id>NCT04459637</nct_id>
  </id_info>
  <brief_title>COVID-19 Surveillance Based on Smart Wearable Device</brief_title>
  <acronym>COVID-19SWD</acronym>
  <official_title>Surveillance of COVID-19 Using Smart Wearable Devices: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center cohort study. 200 subjects with COVID-19will be included&#xD;
      . Wearable device's physiological parameters and clinical data will be continually collected&#xD;
      , the investigators aim to explore whether using smart wearable devices is useful to early&#xD;
      alerting deterioration of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study. 200 subjects aged 18～75y with asymptomatic, mild,&#xD;
      general-type COVID-19 will be recruited. The physiological parameters of wearable devices,&#xD;
      including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records,&#xD;
      will be continuously collected from the day of admission / isolation to 14 days after&#xD;
      discharge or out of quarantine. The Department of Respiratory and Critical Care of Peking&#xD;
      University First Hospital is responsible for this research. All clinical data of patients&#xD;
      during hospitalization will be collected including demographic characteristics, onset time,&#xD;
      visit time, hospitalization time, symptoms, physical examination, laboratory examination,&#xD;
      imaging characteristics, disease severity, treatment and outcome. Primary outcome is the&#xD;
      deterioration of disease, the correlation analysis between the change of wearable device&#xD;
      physiological parameters and the deterioration of disease determined by the traditional&#xD;
      disease evaluation system will be used to find it whether can early alert deterioration of&#xD;
      COVID-19.&#xD;
&#xD;
      The study protocol has been approved by the Peking University First Hospital Institutional&#xD;
      Review Board (IRB) (2020-055). Any protocol modifications will be submitted for the IRB&#xD;
      review and approval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">September 12, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>Deterioration of the condition</measure>
    <time_frame>30 minutes</time_frame>
    <description>Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)&#xD;
The development from asymptomatic to mild/general-type&#xD;
The development from mild to general-type/severe type&#xD;
The development from general-type to severe/critical type&#xD;
The development from severe to critical type</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>14days and/or 28days</time_frame>
    <description>Mortality within 14days and 28days after admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The information analysis degree, the proportion of signal loss, the proportion of wrong signal,</measure>
    <time_frame>30 minutes</time_frame>
    <description>The information analysis degree, the proportion of signal loss, the proportion of wrong signal</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Asymptomatic group</arm_group_label>
    <description>Definition of asymptomatic disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild group</arm_group_label>
    <description>Definition of mild disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>general-type group</arm_group_label>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>severe group</arm_group_label>
    <description>Definition of severe disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>critical group</arm_group_label>
    <description>Definition of critical disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with novel coronavirus infection meeting the criteria of The New Coronavirus&#xD;
        Pneumonia Diagnosis and Treatment Program (Seventh Edition)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 and 75 years(both 18 and 75), either gender;&#xD;
&#xD;
          2. At the time of enrollment, patients with novel coronavirus infection meeting the&#xD;
             criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Seventh&#xD;
             Edition)&#xD;
&#xD;
          3. Able to engage in daily activities;&#xD;
&#xD;
          4. Willing to participate in this research and willing to follow the research program,&#xD;
             with the ability to sign informed consent;&#xD;
&#xD;
          5. having mobile communication equipment which can install APP of wearable device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Wear time of wearable devices &lt;50% during the whole study period&#xD;
&#xD;
          2. Wearable devices have faults, missing signals or errors throughout the study period,&#xD;
             resulting in the proportion of analyzable information &lt;50%&#xD;
&#xD;
          3. Patients with incomplete outpatient and inpatient information and missing core&#xD;
             information such as hospitalization / discharge time, symptoms, laboratory&#xD;
             examination, disease progress record, etc.&#xD;
&#xD;
          4. Patients with serious underlying diseases (including serious mental diseases, mental&#xD;
             disorders, nervous system diseases, malignant tumors, chronic liver diseases, heart&#xD;
             failure, autoimmune diseases, chronic kidney diseases), or life expectancy less than 6&#xD;
             months&#xD;
&#xD;
          5. Unable to take care of themselves in daily life, unable to cooperate with medical&#xD;
             history and data collection&#xD;
&#xD;
          6. participating in other clinical trials;&#xD;
&#xD;
          7. Pregnant women, women in puerperium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Guangfa Wang</investigator_full_name>
    <investigator_title>Professor &amp; MD.</investigator_title>
  </responsible_party>
  <keyword>COVID-19 Surveillance Smart wearable device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459637
org study id: 2020055-0615
nct id: NCT04459637
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Deterioration of the condition
time frame: 30 minutes
description: Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
The development from asymptomatic to mild/general-type
The development from mild to general-type/severe type
The development from general-type to severe/critical type
The development from severe to critical type
measure: Mortality
time frame: 14days and/or 28days
description: Mortality within 14days and 28days after admission
measure: The information analysis degree, the proportion of signal loss, the proportion of wrong signal,
time frame: 30 minutes
description: The information analysis degree, the proportion of signal loss, the proportion of wrong signal
arm group label: Asymptomatic group
description: Definition of asymptomatic disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
arm group label: Mild group
description: Definition of mild disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
arm group label: general-type group
description: 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)
arm group label: severe group
description: Definition of severe disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
arm group label: critical group
description: Definition of critical disease:refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 7)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Guangfa Wang
investigator title: Professor & MD.
mesh term: COVID-19
sharing ipd: No