An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19

NCT ID: NCT05761652

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

378 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-06-01

Brief Summary

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Based on the characteristics of symptoms, differences in physical and chemical examinations and tests, and characteristics of traditional Chinese medicine (TCM) disease differentiation and syndrome differentiation, the evaluation indicators for the clinical early warning model were screened, and the "three-level early warning mechanism for COVID-19 patients at high risks, with progression to severe cases and sequelae was constructed.

Detailed Description

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Adopt multi-level evidence base architecture, build "multi-source data analysis, feature extraction, multi-level evidence extraction, active The integrated Chinese and Western medicine big data platform integrates the original evidence processing into a multi-level evidence base, comprehensive analysis of The platform will generate a multi-level evidence base by processing the original evidence, analyze the evaluation indexes of New Coronary Pneumonia, select the features, build a deep neural network model, train and validate the model, and establish a high The model is trained and validated, and a three-level early warning model is established for people at high risk of new coronary pneumonia, those who turn serious, and those with sequelae.

Conditions

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COVID-19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Modeling group

Observe and record

Intervention Type OTHER

The general information, environmental indicators, and auxiliary examination indicators of the subjects were observed and recorded, as well as the TCM physical assessment was performed.

Validation group

Observe and record

Intervention Type OTHER

The general information, environmental indicators, and auxiliary examination indicators of the subjects were observed and recorded, as well as the TCM physical assessment was performed.

Interventions

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Observe and record

The general information, environmental indicators, and auxiliary examination indicators of the subjects were observed and recorded, as well as the TCM physical assessment was performed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Meeting the diagnostic criteria of mild and moderate types of COVID-19 disease described in the "Diagnostic and Treatment Protocol for Novel Coronavirus Pneumonia (Trial version 9)" \[9\];
2. Age ≥18 years old and ≤90years old;
3. Not more than 5 days after the occurrence of the first symptom (or confirmed onset);
4. The subject agrees to participate the study and have signed the informed consent form by paper signature, electronic signature of mobile software or voice authorization.

Exclusion Criteria

1. Pregnant or lactating women;
2. Patients complicated with severe heart, liver, kidney, blood system and other primary diseases and mental disorders.
3. Patients with disturbance of consciousness, aphasia, dementia and other conditions that prevent them from cooperating with the clinical investigators
4. Patients with incomplete study data.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing YouAn Hospital

OTHER

Sponsor Role collaborator

Kossamak Hospital

UNKNOWN

Sponsor Role collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanhong Zhang, doctor

Role: CONTACT

010-62835861

Maorong Fan, doctor

Role: CONTACT

010-62835377

Facility Contacts

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Zhang, Yanhong

Role: primary

Other Identifiers

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2023XLA003-2

Identifier Type: -

Identifier Source: org_study_id

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