COVID-19CMHSNCT04275947
The COVID-19 Mobile Health Study (CMHS)
An observational study of COVID-19, run by Chinese Alliance Against Lung Cancer at 1 site in China.
Trial summary
This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- nCapp, a cell phone-based auto-diagnosis system
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2020to 31 May 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: -High risk of COVID-19
Who may be able to join
- High risk of COVID-19
- RT-PCR test result of SAR2-CoV-19
Who cannot join
- Not available for RT-PCR test result of SAR2-CoV-19
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Chunxue Bai
Xun Wang
About this study
Official title: The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp
This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.
- Conditions
- COVID-19
- Being tested
- nCapp, a cell phone-based auto-diagnosis system
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCapp, a cell phone-based auto-diagnosis systemOther
Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Training | Not described Receives: Other: nCapp, a cell phone-based auto-diagnosis system | |
| Validation | Not described Receives: Other: nCapp, a cell phone-based auto-diagnosis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of nCapp COVID-19 risk diagnostic model
Sensitivity, specificity and area under the ROC curve of nCapp model
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start14 Feb 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Alliance Against Lung Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Respiratory Research Institution
- Responsible party
- Principal investigator, Bai Chunxue, Chinese Alliance Against Lung Cancer
- Investigators
- Chunxue Bai, Principal investigator, Shanghai Respiratory Research Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275947
- Sponsor's protocol ID
- CAALC-008-CMHS
- Acronym
- CMHS
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anonymous clinical data for training and validation the model
Publications
Yang D, Zhang X, Powell CA, Ni J, Wang B, Zhang J, Zhang Y, Wang L, Xu Z, Zhang L, Wu G, Song Y, Tian W, Hu JA, Zhang Y, Hu J, Hong Q, Song Y, Zhou J, Bai C. Probability of cancer in high-risk patients predicted by the protein-based lung cancer biomarker panel in China: LCBP study. Cancer. 2018 Jan 15;124(2):262-270. doi: 10.1002/cncr.31020. Epub 2017 Sep 20.
PubMed 28940455
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp
- ClinicalTrials.gov ID
- NCT04275947
- Acronym / sponsor ID
- CMHS / CAALC-008-CMHS
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Chinese Alliance Against Lung CancerUniversity, hospital or other
- Collaborators
- Shanghai Respiratory Research Institution
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 19 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.
This study evaluates a brand-new cell phone-based auto-diagnosis system, which is based on the clinical guidelines, clinical experience, and statistic training model. We will achieve secure and 1st hand data from physicians in Wuhan, which including 150 cases in the training cohort and 300 cases in the validation cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | – | Other: nCapp, a cell phone-based auto-diagnosis system |
| Validation | – | Other: nCapp, a cell phone-based auto-diagnosis system |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -High risk of COVID-19
Key inclusion criteria (2 listed)
- High risk of COVID-19
- RT-PCR test result of SAR2-CoV-19
Key exclusion criteria (1 listed)
- Not available for RT-PCR test result of SAR2-CoV-19
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 |
|---|---|---|
| nCapp, a cell phone-based auto-diagnosis systemCombined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19 | Other | Training, Validation |
Primary outcome
Accuracy of nCapp COVID-19 risk diagnostic model
Time frame: 1 day
Sensitivity, specificity and area under the ROC curve of nCapp model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 28940455Yang D, Zhang X, Powell CA, Ni J, Wang B, Zhang J, Zhang Y, Wang L, Xu Z, Zhang L, Wu G, Song Y, Tian W, Hu JA, Zhang Y, Hu J, Hong Q, Song Y, Zhou J, Bai C. Probability of cancer in high-risk patients predicted by the protein-based lung cancer biomarker panel in China: LCBP study. Cancer. 2018 Jan 15;124(2):262-270. doi: 10.1002/cncr.31020. Epub 2017 Sep 20.
- Individual participant dataSharing planned: Undecided. The anonymous clinical data for training and validation the model
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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.
Chunxue Bai principal investigator
Shanghai Respiratory Research Institution
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 COVID-19, run by Chinese Alliance Against Lung Cancer 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxue Bai (+8618621170011, bai.chunxue@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of nCapp COVID-19 risk diagnostic model (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275947, which also lists 1 linked publication.
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 19 Feb 2020.