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NCT04275947 Clinical Trial

The COVID-19 Mobile Health Study (CMHS)

COVID-19 Clinical Trial

— CMHS  

Official title:
The COVID-19 Mobile Health Study, a Large-scale Clinical Observational Study Using nCapp

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04275947
Other study ID # CAALC-008-CMHS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 14, 2020
Est. completion date May 31, 2020

Study information
Verified date February 2020
Source Chinese Alliance Against Lung Cancer
Contact Chunxue Bai
Phone +8618621170011?
Email bai.chunxue@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 cohort.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date May 31, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

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

Locations
Country Name City State
China Renmin Hospital of Wuhan University Wuhan Hubei

Sponsors (2)
Lead Sponsor Collaborator
Chinese Alliance Against Lung Cancer Shanghai Respiratory Research Institution

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of nCapp COVID-19 risk diagnostic model Sensitivity, specificity and area under the ROC curve of nCapp model 1 day
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