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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761652
• Other study ID #: 2023XLA003-2
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2023
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Yanhong Zhang, doctor
• Phone: 010-62835861
• Email: zhangyanhong818[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 378
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijin

Sponsors (4)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing YouAn Hospital, Kamuzu University of Health Sciences, Kossamak Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Data:	including age, underlying diseases, body weight, occupation, smoking, alcohol drinking, salt intake and exercise	Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Primary	Environment Indicators:	air temperature, humidity, and air quality	Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Primary	Auxiliary Examination Indicators:	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	Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Primary	TCM based Evaluation:	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	Not more than 5 days after the occurrence of the first symptom (or confirmed onset)