Clinical trial NCT05761652: An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19
Official title: An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: Early Warning Model
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Kossamak Hospital
name: Kamuzu University of Health Sciences
First posted: 2023-03-09
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: General Data:
timeFrame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
measure: Environment Indicators:
timeFrame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
measure: Auxiliary Examination Indicators:
timeFrame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
measure: TCM based Evaluation:
timeFrame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijin
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study officials:
References: