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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05761652
Enrollment
378
Registered
2023-03-09
Start date
2022-12-01
Completion date
2024-06-01
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Early Warning Model

Brief summary

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

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.

Interventions

OTHERObserve 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.

Sponsors

Beijing YouAn Hospital
CollaboratorOTHER
Kossamak Hospital
CollaboratorUNKNOWN
Kamuzu University of Health Sciences
CollaboratorOTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
General Data:Not more than 5 days after the occurrence of the first symptom (or confirmed onset)including age, underlying diseases, body weight, occupation, smoking, alcohol drinking, salt intake and exercise
Environment Indicators:Not more than 5 days after the occurrence of the first symptom (or confirmed onset)air temperature, humidity, and air quality
Auxiliary Examination Indicators:Not more than 5 days after the occurrence of the first symptom (or confirmed onset)blood routine (lymphocyte count, lymphocyte/neutrophil ratio), four coagulation items (PT, APTT, TT, FIB), D-Di, C-reactive protein, erythrocyte sedimentation rate, liver function (ALT, AST, ALP), renal function (BUN, Cr), blood glucose, lung CT
TCM based Evaluation:Not more than 5 days after the occurrence of the first symptom (or confirmed onset)TCM constitution differentiation With reference to the Classification and Determination of Constitutions in TCM issued by the China Association of Traditional Chinese Medicine. There are nine constitution types based on TCM syndrome differentiation

Countries

China

Contacts

Primary ContactYanhong Zhang, doctor
zhangyanhong818@163.com010-62835861
Backup ContactMaorong Fan, doctor
fanmr1974@qq.com010-62835377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026