- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275947
The COVID-19 Mobile Health Study (CMHS) (CMHS)
February 17, 2020 updated by: Bai Chunxue, Chinese Alliance Against Lung Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chunxue Bai
- Phone Number: +8618621170011
- Email: bai.chunxue@zs-hospital.sh.cn
Study Contact Backup
- Name: Dawei Yang
- Phone Number: +8613564703813
- Email: yang.dawei@zs-hospital.sh.cn
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Renmin Hospital of Wuhan University
-
Sub-Investigator:
- Maosong Ye
-
Contact:
- Chunxue Bai
-
Sub-Investigator:
- Xun Wang
-
Sub-Investigator:
- Jie Liu
-
Sub-Investigator:
- Chunlin Dong
-
Sub-Investigator:
- Yong Zhang
-
Principal Investigator:
- Chunxue Bai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
-High risk of COVID-19
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Validation
|
Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19
|
Training
|
Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of nCapp COVID-19 risk diagnostic model
Time Frame: 1 day
|
Sensitivity, specificity and area under the ROC curve of nCapp model
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chunxue Bai, Shanghai Respiratory Research Institution
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2020
Primary Completion (Anticipated)
April 30, 2020
Study Completion (Anticipated)
May 31, 2020
Study Registration Dates
First Submitted
February 17, 2020
First Submitted That Met QC Criteria
February 17, 2020
First Posted (Actual)
February 19, 2020
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 17, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAALC-008-CMHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The anonymous clinical data for training and validation the model
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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