Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients

NCT ID: NCT04456101

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-19

Study Completion Date

2023-12-12

Brief Summary

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The intent of this study was to examine the health status of individuals who had been confirmed with COVID-19 in the year after their recovery. Parameters studied included serum levels of SARS coronavirus 2 (SARS-CoV 2) IgG antibody, SARS-CoV-2 nucleic acid test, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), lung function test, imaging data and airway microbiota data. In addition, we explored the systematic Immune \& Inflammation in some of the individuals recovering from COVID-19.

Detailed Description

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About 20% of COVID-19 developed into a critical illness and about 2% died. The global epidemic continues to develop, but some patients in China have entered the rehabilitation period, which is accompanied by a large number of respiratory symptoms and pulmonary fibrosis, bringing serious harm to the country. Therefore, early accurate detection and prediction of the development trend of patients in rehabilitation period and targeted treatment measures for corresponding patients are the key to the success of COVID-19 rehabilitation period. It will play a key role in the stratified management of the post-epidemic situation, which is crucial to improve the quality of life of COVID-19 patients. We aim to explore the clinical characteristics of rehabilitation patients by detecting some indicators of patients in rehabilitation period, including serum IgG and IgM antibody of SARS-CoV 2, SARS-CoV-2 nucleic acid, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary function, chest CT imaging, systematic Immune \& Inflammation states.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

healthy individuals without COVID-19

No interventions assigned to this group

Severe/Critical COVID-19 rehabilitation group

â‘ Individuals recovering from Severe/Critical COVID-19

No interventions assigned to this group

mild/moderate COVID-19 rehabilitation group

Individuals recovering from mild/moderate COVID-19

No interventions assigned to this group

asymptomatic COVID-19 rehabilitation group

Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with laboratory test for SRARS-COV2 turning negative, or healthy volunteers without COVID-19.
2. The age range is 18-80 years.
3. Subjects or their family members agree to participate in the study and sign informed consent.
4. The previously diagnosed individuals have been cured for about 1 month.

Exclusion Criteria

1. Woman who is breastfeeding, pregnant, or preparing to become pregnant.
2. Patients with cognitive impairment or poor compliance as determined by the investigator.
3. Participants in other clinical trials.
4. Subjects who were not suitable for clinical trials determined by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yang Jin

Department of Respiratory and Critical Care Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Jin, professor

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Juanjuan Xu, professor

Role: CONTACT

15972930101

Facility Contacts

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Yang Jin, MD

Role: primary

Other Identifiers

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NCIP03

Identifier Type: -

Identifier Source: org_study_id

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