NCT04275947

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

February 17, 2020

Last Update Submit

February 17, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Accuracy of nCapp COVID-19 risk diagnostic model

    Sensitivity, specificity and area under the ROC curve of nCapp model

    1 day

Study Arms (2)

Training

Other: nCapp, a cell phone-based auto-diagnosis system

Validation

Other: nCapp, a cell phone-based auto-diagnosis system

Interventions

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

TrainingValidation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

-High risk of COVID-19

You may qualify if:

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

You may not qualify if:

  • Not available for RT-PCR test result of SAR2-CoV-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Related 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.

    PMID: 28940455BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chunxue Bai

    Shanghai Respiratory Research Institution

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxue Bai

CONTACT

+8618621170011‬bai.chunxue@zs-hospital.sh.cn

Dawei Yang

CONTACT

+8613564703813yang.dawei@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 14, 2020

Primary Completion

April 30, 2020

Study Completion

May 31, 2020

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

CN(1)