COVID-19NCT04456101
Study on the Recovery of Pulmonary Function, Chest CT, Airway Microbiota, Hematologic, and Immune & Inflammatory Conditions in COVID-19 Rehabilitation Patients
An observational study of COVID-19, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2020to 12 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Covid-19 rehabilitation was the experimental group, and the healthy control group was the conventional control group
Who may be able to join
- Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with laboratory test for SRARS-COV2 turning negative, or healthy volunteers without COVID-19.
- The age range is 18-80 years.
- Subjects or their family members agree to participate in the study and sign informed consent.
- The previously diagnosed individuals have been cured for about 1 month.
Who cannot join
- Woman who is breastfeeding, pregnant, or preparing to become pregnant.
- Patients with cognitive impairment or poor compliance as determined by the investigator.
- Participants in other clinical trials.
- Subjects who were not suitable for clinical trials determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yang Jin, MD
About this study
Official title: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.
Read the detailed description
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
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | healthy individuals without COVID-19 | |
| Severe/Critical COVID-19 rehabilitation group | ①Individuals recovering from Severe/Critical COVID-19 | |
| mild/moderate COVID-19 rehabilitation group | Individuals recovering from mild/moderate COVID-19 | |
| asymptomatic COVID-19 rehabilitation group | Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) for lung volume, peak expiratory flow (PEF) for velocity, carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.
Measured: an average of 1 to 3 months after recovery
Chest CT
Percentage of lungs that contain reticular patterns, Percentage of lungs that contain pure ground-glass opacification, Percentage of lungs that contain honeycombing, Percentage of lungs that contain traction bronchiectasis, Percentage of lungs that contain strip-like consolidation.
Measured: an average of 1 to 3 months after recovery
Changes in hematology
blood routine indexes included leucocytes(×109/L), neutrophils(×109/L), lymphocytes(×109/L), monocytes(×109/L), eosinophils(×109/L), platelets(×109/L). Biochemical and coagulation function indicators included total protein(umol/L), creatinine (umol/L), uric acid (umol/L), lactic dehydrogenase(U/L), C-reactive protein (mg/L), aspartate aminotransferase (U/L), glutamic-pyruvic transaminase (U/L), D-dimer,(ug/L), fibrinogen(g/L), Active part thrombin time (APTT), prothrombin time (PT), thrombin time (TT) and troponin (TNI).
Measured: an average of 1 to 3 months after recovery
Changes in immune and inflammatory states
Immune cells and related cell factors included CD8+T cell(×109/L), CD4+T cell(×109/L), bone marrow derived suppressor cells(×109/L), regulatory T cells(×109/L), natural killer cell(×109/L), dendritic cell(×109/L), macrophages(×109/L), interleukin-4(IL-4)ug/L, IL-2 ug/L, IL-17 ug/L, IL-15 ug/L, IL-16 ug/L, IL-1 ug/L, IL-6 ug/L, IL-10 ug/L, tumor necrosis factor ug/L, interferon gamma ug/L, eotaxin-3 ug/L, eotaxin ug/L.
Measured: an average of 1 to 3 months after recovery
St. George's Respiratory Questionnaire(SGRQ)
St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.
Measured: an average of 1 to 3 months after recovery
Modified British medical research council (mMRC)
mMRC only reflects symptom of dyspnea. A score of 0-1 is considered as fewer symptom, and ≥2 is considered as more symptom.
Measured: an average of 1 to 3 months after recovery
COPD Assessment test (CAT)
CAT score was a comprehensive symptom score ranging from 0 to 40 points. The higher the score, the worse the lung.
Measured: an average of 1 to 3 months after recovery
Airway Microbiota
Airway Microbiota of exhaled breath condensate in individuals were detected.
Measured: an average of 1 to 3 months after recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start19 Jun 2020
- Primary completion12 Dec 2023 (estimated)
- Study completion12 Dec 2023 (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.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jin, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Yang Jin, professor, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456101
- Sponsor's protocol ID
- NCIP03
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2020
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- ClinicalTrials.gov ID
- NCT04456101
- Acronym / sponsor ID
- NCIP03
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 2 Jul 2020 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –healthy individuals without COVID-19 |
| Severe/Critical COVID-19 rehabilitation group | – | –①Individuals recovering from Severe/Critical COVID-19 |
| mild/moderate COVID-19 rehabilitation group | – | –Individuals recovering from mild/moderate COVID-19 |
| asymptomatic COVID-19 rehabilitation group | – | –Asymptomatic COVID-19 individuals with laboratory test for SRARS-COV2 turning negative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Covid-19 rehabilitation was the experimental group, and the healthy control group was the conventional control group
Key inclusion criteria (4 listed)
- Individuals recovering from COVID-19, or asymptomatic COVID-19 patients with laboratory test for SRARS-COV2 turning negative, or healthy volunteers without COVID-19.
- The age range is 18-80 years.
- Subjects or their family members agree to participate in the study and sign informed consent.
- The previously diagnosed individuals have been cured for about 1 month.
Key exclusion criteria (4 listed)
- Woman who is breastfeeding, pregnant, or preparing to become pregnant.
- Patients with cognitive impairment or poor compliance as determined by the investigator.
- Participants in other clinical trials.
- Subjects who were not suitable for clinical trials determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary Function
Time frame: an average of 1 to 3 months after recovery
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) for lung volume, peak expiratory flow (PEF) for velocity, carbon monoxide diffusion capacity (DLCO) for pulmonary diffusion function.
Chest CT
Time frame: an average of 1 to 3 months after recovery
Percentage of lungs that contain reticular patterns, Percentage of lungs that contain pure ground-glass opacification, Percentage of lungs that contain honeycombing, Percentage of lungs that contain traction bronchiectasis, Percentage of lungs that contain strip-like consolidation.
Changes in hematology
Time frame: an average of 1 to 3 months after recovery
blood routine indexes included leucocytes(×109/L), neutrophils(×109/L), lymphocytes(×109/L), monocytes(×109/L), eosinophils(×109/L), platelets(×109/L). Biochemical and coagulation function indicators included total protein(umol/L), creatinine (umol/L), uric acid (umol/L), lactic dehydrogenase(U/L), C-reactive protein (mg/L), aspartate aminotransferase (U/L), glutamic-pyruvic transaminase (U/L), D-dimer,(ug/L), fibrinogen(g/L), Active part thrombin time (APTT), prothrombin time (PT), thrombin time (TT) and troponin (TNI).
Changes in immune and inflammatory states
Time frame: an average of 1 to 3 months after recovery
Immune cells and related cell factors included CD8+T cell(×109/L), CD4+T cell(×109/L), bone marrow derived suppressor cells(×109/L), regulatory T cells(×109/L), natural killer cell(×109/L), dendritic cell(×109/L), macrophages(×109/L), interleukin-4(IL-4)ug/L, IL-2 ug/L, IL-17 ug/L, IL-15 ug/L, IL-16 ug/L, IL-1 ug/L, IL-6 ug/L, IL-10 ug/L, tumor necrosis factor ug/L, interferon gamma ug/L, eotaxin-3 ug/L, eotaxin ug/L.
St. George's Respiratory Questionnaire(SGRQ)
Time frame: an average of 1 to 3 months after recovery
St. George's Respiratory Questionnaire total score(0-3989.4), St. George's Respiratory Questionnaire symptoms score(0-662.5); St. George's Respiratory Questionnaire impacts score(0-2117.8); St. George's Respiratory Questionnaire activity score(0-1209.1). The higher the score, the worse the lung.
Modified British medical research council (mMRC)
Time frame: an average of 1 to 3 months after recovery
mMRC only reflects symptom of dyspnea. A score of 0-1 is considered as fewer symptom, and ≥2 is considered as more symptom.
COPD Assessment test (CAT)
Time frame: an average of 1 to 3 months after recovery
CAT score was a comprehensive symptom score ranging from 0 to 40 points. The higher the score, the worse the lung.
Airway Microbiota
Time frame: an average of 1 to 3 months after recovery
Airway Microbiota of exhaled breath condensate in individuals were detected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Yang Jin, professor principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 27 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 Juanjuan Xu, professor (15972930101, whuhjy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function (time frame: an average of 1 to 3 months after recovery). The study lists 8 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 27 Mar 2023.