COVID-19NCT05761652
An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19
An observational study of COVID-19, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Observe and record
- How many people
- 378 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COVID-19 patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijin, 100091
Zhang, Yanhong
About this study
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Observe and record
- Keywords
- Early Warning Model
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe and recordOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Modeling group | Not described Receives: Other: Observe and record | |
| Validation group | Not described Receives: Other: Observe and record |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Data:
including age, underlying diseases, body weight, occupation, smoking, alcohol drinking, salt intake and exercise
Measured: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Environment Indicators:
air temperature, humidity, and air quality
Measured: 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
Measured: 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
Measured: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing YouAn Hospital, Kossamak Hospital, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761652
- Sponsor's protocol ID
- 2023XLA003-2
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Warning Model for Assessing the Onset, Progression and Sequelae of COVID-19
- ClinicalTrials.gov ID
- NCT05761652
- Acronym / sponsor ID
- 2023XLA003-2
- Conditions
- COVID-19
- Keywords
- Early Warning Model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing YouAn Hospital, Kossamak Hospital, Kamuzu University of Health Sciences
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling group | – | Other: Observe and record |
| Validation group | – | Other: Observe and record |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observe and recordThe general information, environmental indicators, and auxiliary examination indicators of the subjects were observed and recorded, as well as the TCM physical assessment was performed. | Other | Modeling group, Validation group |
Primary outcome
General Data:
Time frame: 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:
Time frame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
air temperature, humidity, and air quality
Auxiliary Examination Indicators:
Time frame: 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:
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Zhang, doctor (010-62835861, zhangyanhong818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Data: (time frame: Not more than 5 days after the occurrence of the first symptom (or confirmed onset)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.