Susceptibility to Viral and Mycobacterial InfectionCOVID-19NCT04256395
Efficacy of a Self-test and Self-alert Mobile Applet in Detecting Susceptible Infection of COVID-19
An observational study of Susceptibility to Viral and Mycobacterial Infection, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Susceptibility to Viral and Mycobacterial Infection
- What is being tested?
- mobile internet survey on self-test
- How many people
- 102,456 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- people who are not internet accessible or can not use this Mobile Applet.
- people who can not recognize the questionnaire.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official 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
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.
Read the detailed description
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. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people，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.
- Being tested
- mobile internet survey on self-test
- Keywords
- registry study, novel coronavirus（COVID-19）, mobile internet survey
- Medical subject headings
- Mycobacterium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile internet survey on self-testOther
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Secondary outcomes (3)
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
Measured: 5 month
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.
Measured: 5 month
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.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Susceptibility to Viral and Mycobacterial InfectionStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for precision medicine of Tsinghua University, Institute for artificial intelligent of Tsinghua University, Chinese Medical Doctor Association, Institute for network behavior of Tsinghua University, school of clinical medicine of Tsinghua University
- Responsible party
- Sponsor
- Investigators
- Jiahong Dong, M.D, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256395
- Sponsor's protocol ID
- RWS-BTCH-002
- Acronym
- COVID-19
- Status last verified
- Jul 2020
- First submitted
- 1 Feb 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04256395
- Acronym / sponsor ID
- COVID-19 / RWS-BTCH-002
- Keywords
- registry study, novel coronavirus（COVID-19）, mobile internet survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102,456 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Institute for precision medicine of Tsinghua University, Institute for artificial intelligent of Tsinghua University, Chinese Medical Doctor Association, Institute for network behavior of Tsinghua University, school of clinical medicine of Tsinghua University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This survey was also advocated by Chinese Medical Doctor Association. Residents , or even oversea Chinese people，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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- people who lived in or out of China at present and threatened by the infection and spread of COVID-19
Key exclusion criteria (2 listed)
- people who are not internet accessible or can not use this Mobile Applet.
- people who can not recognize the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile internet survey on self-test1. 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. | Other | – |
Primary outcome
positive number diagnosed by national guideline in the evaluated population
Time frame: 5 months
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
3 secondary outcomes
distribution map of evaluated people
Time frame: 5 month
Effect of medical guidance by designated feedback questionnaire
Time frame: 5 month
mental scale of relief the mental anxiety and avoid unnecessary outpatient
Time frame: 5 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiahong Dong, M.D principal investigator
Beijing Tsinghua Changgeng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Susceptibility to Viral and Mycobacterial Infection, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive number diagnosed by national guideline in the evaluated population (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.