An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19
1 other identifier
observational
378
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedMarch 9, 2023
February 1, 2023
1.2 years
March 8, 2023
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Study Arms (2)
Modeling group
Validation group
Interventions
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.
Eligibility Criteria
COVID-19 patients
You may qualify if:
- 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)" \[9\];
- Age ≥18 years old and ≤90years old;
- Not more than 5 days after the occurrence of the first symptom (or confirmed onset);
- 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.
You may not qualify if:
- Pregnant or lactating women;
- Patients complicated with severe heart, liver, kidney, blood system and other primary diseases and mental disorders.
- Patients with disturbance of consciousness, aphasia, dementia and other conditions that prevent them from cooperating with the clinical investigators
- Patients with incomplete study data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Scienceslead
- Beijing YouAn Hospitalcollaborator
- Kossamak Hospitalcollaborator
- Kamuzu University of Health Sciencescollaborator
Study Sites (1)
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijin, 100091, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 9, 2023
Study Start
December 1, 2022
Primary Completion
February 1, 2024
Study Completion
June 1, 2024
Last Updated
March 9, 2023
Record last verified: 2023-02