Susceptibility to Viral and Mycobacterial Infection Clinical Trial
— COVID-19Official title:
Registry Study on the Efficacy of a Self-test and Self-alert Applet in Detecting Susceptible Infection of COVID-19 ——a Population Based Mobile Internet Survey
| NCT number | NCT04256395 |
| Other study ID # | RWS-BTCH-002 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2020 |
| Est. completion date | July 1, 2020 |
| Verified date | July 2020 |
| Source | Beijing Tsinghua Chang Gung Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 102456 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | July 1, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - people who are not internet accessible or can not use this Mobile Applet. - people who can not recognize the questionnaire. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Tsinghua Changgung Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tsinghua Chang Gung Hospital | Chinese Medical Doctor Association, Institute for artificial intelligent of Tsinghua University, Institute for network behavior of Tsinghua University, Institute for precision medicine of Tsinghua University, school of clinical medicine of Tsinghua University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | distribution map of evaluated people | after the end of this study, investigators calculate the proportion and distribution of evaluated people with normal and abnormal scores | 5 month | |
| Secondary | Effect of medical guidance by designated feedback questionnaire | after the end of this study, investigators sent the feedback inform to every evaluated people and collect and analysis the response to find out whether this applet can help them in the following surveillance or medical treatment. And how it works. | 5 month | |
| Secondary | mental scale of relief the mental anxiety and avoid unnecessary outpatient | after the end of this study, investigators sent the designated mental scale including anxiety, and collect the response and draw the conclusion. | 5 month |