Risk Identification of Long-term Complications
May 7, 2024 updated by: Wuhan Central Hospital
Risk Identification of Long-term Complications in the Recover Patients With Severe COVID-19
The investigators retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe COVID-19, and strengthen follow-up to improve the prognosis of patients.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
At present, there is a lack of prediction models for the long-term complications of severe COVID-19.
Therefore, the investigators used the hospital big data platform to retrospectively analyze the clinical characteristics of severe COVID-19 in our hospital, and conducted cohort follow-up of the changes in lung function including FEV1, FVC，FEV1% and DLCO, etc and and high-resolution CT of patients after discharge.
COX model and other statistical methods were used to establish a prediction model for long-term complications of severe COVID-19, and early identification and intervention, strengthen follow-up, and improve the prognosis of patients.
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wuhan, China, 430000
- Follow-up of patients with severe COVID-19
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with severe COVID-19 in our hospital from December 8, 2022 to January 31, 2023 were enrolled
Description
Inclusion Criteria:
The patient met the diagnostic criteria for severe COVID-19
Exclusion Criteria:
- Pregnant women Patients who died of COVID-19 Patients younger than 18 years of age without pulmonary CT
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 |
Intervention / Treatment |
|---|---|
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Follow-up cohort of patients with severe COVID-19
The scores of various scales, pulmonary function and imaging changes of patients with severe COVID-19 were collected at 3 months, 6 months and 12 months after rehabilitation and discharge.
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According to the pulmonary rehabilitation guidelines, patients with severe COVID-19 were given regular rehabilitation treatment, including breathing exercises and physical rehabilitation exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lung function
Time Frame: 1 year
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Pulmonary function indicators improved gradually
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1 year
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Imaging of the lung
Time Frame: 1 year
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The residual lesions in the lung were gradually absorbed
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 1, 2023
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
October 8, 2023
First Submitted That Met QC Criteria
January 29, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230922
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The project confidentiality agreement was observed, but the IPD could be made public after the study was completed.
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.