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The COVID-19 Mobile Health Study (CMHS) (CMHS)

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ClinicalTrials.gov Identifier: NCT04275947
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Shanghai Respiratory Research Institution
Information provided by (Responsible Party):
Bai Chunxue, Chinese Alliance Against Lung Cancer

Tracking Information
First Submitted Date February 17, 2020
First Posted Date February 19, 2020
Last Update Posted Date February 19, 2020
Actual Study Start Date February 14, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2020)
Accuracy of nCapp COVID-19 risk diagnostic model [ Time Frame: 1 day ]
Sensitivity, specificity and area under the ROC curve of nCapp model
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The COVID-19 Mobile Health Study (CMHS)
Official Title The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp
Brief 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 cohort.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population -High risk of COVID-19
Condition COVID-19
Intervention Other: nCapp, a cell phone-based auto-diagnosis system
Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19
Study Groups/Cohorts
  • Training
    Intervention: Other: nCapp, a cell phone-based auto-diagnosis system
  • Validation
    Intervention: Other: nCapp, a cell phone-based auto-diagnosis system
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 17, 2020)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • High risk of COVID-19
  • RT-PCR test result of SAR2-CoV-19

Exclusion Criteria:

  • Not available for RT-PCR test result of SAR2-CoV-19
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Chunxue Bai +8618621170011‬ bai.chunxue@zs-hospital.sh.cn
Contact: Dawei Yang +8613564703813 yang.dawei@zs-hospital.sh.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04275947
Other Study ID Numbers CAALC-008-CMHS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: The anonymous clinical data for training and validation the model
Responsible Party Bai Chunxue, Chinese Alliance Against Lung Cancer
Study Sponsor Chinese Alliance Against Lung Cancer
Collaborators Shanghai Respiratory Research Institution
Investigators
Principal Investigator: Chunxue Bai Shanghai Respiratory Research Institution
PRS Account Chinese Alliance Against Lung Cancer
Verification Date February 2020