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

March 8, 2023 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
378

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
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
Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
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
Not more than 5 days after the occurrence of the first symptom (or confirmed onset)
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
Not more than 5 days after the occurrence of the first symptom (or confirmed onset)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing YouAn Hospital
Kossamak Hospital
Kamuzu University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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