COVID-19 Surveillance Based on Smart Wearable Device

COVID-19 Clinical Trial

— COVID-19SWD  

Official title:

Surveillance of COVID-19 Using Smart Wearable Devices: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459637
• Other study ID #: 2020055-0615
• Status: Completed
• Start date: August 2, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: March 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 15, 2021
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deterioration of the condition	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	30 minutes
Secondary	Mortality	Mortality within 14days and 28days after admission	14days and/or 28days
Secondary	The information analysis degree, the proportion of signal loss, the proportion of wrong signal,	The information analysis degree, the proportion of signal loss, the proportion of wrong signal	30 minutes