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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Observe and record

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.

• Study Type: Observational
• Enrollment (Anticipated): 378

Contacts and Locations

• Study Contact: Name: Yanhong Zhang, doctor; Phone Number: 010-62835861; Email: zhangyanhong818@163.com
• Study Contact Backup: Name: Maorong Fan, doctor; Phone Number: 010-62835377; Email: fanmr1974@qq.com

Study Locations

• China
  • Beijin, China, 100091
    • Recruiting
    • Xiyuan Hospital of China Academy of Chinese Medical Sciences
    • Contact: Zhang, Yanhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Validation group	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.
Modeling group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Environment Indicators:	air temperature, humidity, and air quality	Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
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)
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)

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing YouAn Hospital; Kossamak Hospital; Kamuzu University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Early Warning Model
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2023XLA003-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No