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 Locations

  • China
    • 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
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
Training
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

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.

Sponsor

Chinese Alliance Against Lung Cancer

Collaborators

Shanghai Respiratory Research Institution

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.

General Publications

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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