NCT04256395

Brief Summary

The "COVID-19 infection self-test and alert system" (hereinafter referred to as "COVID-19 self-test applet") jointly developed by Beijing Tsinghua Changgung Hospital, Institute for precision medicine, artificial intelligence of Tsinghua University was launched on February 1,2020. Residents , according to their actual healthy situation, after answering questions online, the system will conduct intelligent analysis, make disease risk assessment and give healthcare and medical guidance. Based on the Internet population survey, and referring to the diagnosis and screening standards of the National Health Commission of the People's Republic of China, investigators carried out the mobile applet of Internet survey and registry study for the Internet accessible identifiable population, so as to screen the suspected population and guide the medical treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102,456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

February 1, 2020

Last Update Submit

July 5, 2020

Conditions

Keywords

registry studynovel coronavirus(COVID-19)mobile internet survey

Outcome Measures

Primary Outcomes (1)

  • positive number diagnosed by national guideline in the evaluated population

    after the end of this study, investigators calculate and sum up the total evaluated population and positively diagnosed population, then check the ROC of this system, finally to calculate the sensitivity and accuracy of this self-test and self-alert system

    5 months

Secondary Outcomes (3)

  • distribution map of evaluated people

    5 month

  • Effect of medical guidance by designated feedback questionnaire

    5 month

  • mental scale of relief the mental anxiety and avoid unnecessary outpatient

    5 month

Interventions

1\. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Most people including healthy or susceptible patients or diagnosed patients will be enrolled. People whoever worry about his heath status relating with infection of COVID-19 at present can register and answer the question and get a score for risk evaluation. If a high risk achieved, the applet will guide the interviewer for further medical diagnosis and treatment.

You may qualify if:

  • people who lived in or out of China at present and threatened by the infection and spread of COVID-19
  • without gender and age restriction
  • people who have concerns of his health
  • voluntary completion of the self-test and evaluation.

You may not qualify if:

  • people who are not internet accessible or can not use this Mobile Applet.
  • people who can not recognize the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Mycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Jiahong Dong, M.D

    Beijing Tsinghua Changgeng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

February 1, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations