PrognosisNCT05004246
Longitudinal Changes in Characteristics of COVID-19 Survivors and Their Long-term Follow-up Study
An observational study of Prognosis and Sequelae, run by Tongji Hospital at 1 site in China.
Trial summary
Follow-up study of Coronavirus disease 2019 (COVID-19) survivors has rarely been reported. We aimed to investigate longitudinal changes in the characteristics of COVID-19 survivors after discharge. Read more about this study
- Who is it for?
- Any age
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll recovered patients with confirmed COVID-19 who were discharged from Hospital.
Who may be able to join
- Patients with confirmed COVID-19 who have complete hospitalization data.
Who cannot join
- Suspected cases of COVID-19.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of infectious disease, Tongji Hospital
Wuhan, Hubei, 430030
About this study
Follow-up study of Coronavirus disease 2019 (COVID-19) survivors has rarely been reported. We aimed to investigate longitudinal changes in the characteristics of COVID-19 survivors after discharge.
Read the detailed description
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. Numerous studies have been performed so far to investigate clinical characteristics, risk factors, potential treatment and pathogenesis of COVID-19. However, little information is available on the long-term prognosis and possible sequelae of COVID-19 survivors who have recovered and been discharged from hospital. Hence, the investigators conducted a prospective study to investigate the long-time prognosis and the possible sequelae of COVID-19 survivors. The investigators evaluated Demographic and clinical characteristics, laboratory and radiological findings,pulmonary function tests, electrocardiogram, complications as well as treatment and symptoms and signs of COVID-19 patients.
- Keywords
- COVID-19, follow-up, consequences
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms and signs
symptoms and signs will be collected.
Measured: 1-3years
SF-36 Questionnaire to the ability of Life
Quality of Life will be assesed using the MOS item short from health survey（SF-36.Minimum value:0, Maximum value: 100. Higher scores mean a better outcome.
Measured: 1-3years
Mental quality
Mental quality will be assessed using hospital anxiety and depression scale.Minimum value:0, Maximum value: 21. Higher scores mean a worse outcome.
Measured: 1-3years
laboratory findings,change from baseline for blood laboratory measures
the change from baseline for laboratory examination （Hb in g/L, Leukocyte in /L, neutrophil count in /L，lymphocyte count in /L，Platelet count in /L，Creatinine in μmol/L, Bilirubin in mg/dL, ALP in U/L, γ-glutamyl transpeptidase in U/L，AST in U/L, ALT in U/L, Albumin in g/dL, triglycerides in mmol/L, total cholesterol in mmol/L，cardiac troponin I in ng/mL， myoglobin in ng/mL， brain natriuretic peptide precursors in pg/mL， lactate dehydrogenase in U/L, Creatine Kinase in U/L).
Measured: 1-3years
Radiological findings
Radiological findings such as chest computed tomography will be assessed.
Measured: 1-3years
pulmonary function
pulmonary function tests will be assessed.
Measured: 1-3years
Heart function
electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.（they have no Units）
Measured: 1-3years
Abdominal ultrasound
Abdominal ultrasound will be assessed.
Measured: 1-3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrognosisStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Yichang Central People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Yunnan Provincial Infectious Disease Hospital, WUHAN Number Seven HOSPITAL, Shanxi Bethune Hospital
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004246
- Sponsor's protocol ID
- TJ20210622
- Status last verified
- Mar 2024
- First submitted
- 21 Jul 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Characteristics of COVID-19 Survivors and Their Long-term Follow-up Study
- ClinicalTrials.gov ID
- NCT05004246
- Acronym / sponsor ID
- TJ20210622
- Keywords
- COVID-19, follow-up, consequences
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Yichang Central People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Yunnan Provincial Infectious Disease Hospital, WUHAN Number Seven HOSPITAL, Shanxi Bethune Hospital
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Aug 2021 (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.
Follow-up study of Coronavirus disease 2019 (COVID-19) survivors has rarely been reported. We aimed to investigate longitudinal changes in the characteristics of COVID-19 survivors after discharge.
Detailed description
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. Numerous studies have been performed so far to investigate clinical characteristics, risk factors, potential treatment and pathogenesis of COVID-19. However, little information is available on the long-term prognosis and possible sequelae of COVID-19 survivors who have recovered and been discharged from hospital. Hence, the investigators conducted a prospective study to investigate the long-time prognosis and the possible sequelae of COVID-19 survivors. The investigators evaluated Demographic and clinical characteristics, laboratory and radiological findings,pulmonary function tests, electrocardiogram, complications as well as treatment and symptoms and signs of COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll recovered patients with confirmed COVID-19 who were discharged from Hospital.
Key inclusion criteria (1 listed)
- Patients with confirmed COVID-19 who have complete hospitalization data.
Key exclusion criteria (1 listed)
- Suspected cases of COVID-19.
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
symptoms and signs
Time frame: 1-3years
symptoms and signs will be collected.
SF-36 Questionnaire to the ability of Life
Time frame: 1-3years
Quality of Life will be assesed using the MOS item short from health survey（SF-36.Minimum value:0, Maximum value: 100. Higher scores mean a better outcome.
Mental quality
Time frame: 1-3years
Mental quality will be assessed using hospital anxiety and depression scale.Minimum value:0, Maximum value: 21. Higher scores mean a worse outcome.
laboratory findings,change from baseline for blood laboratory measures
Time frame: 1-3years
the change from baseline for laboratory examination （Hb in g/L, Leukocyte in /L, neutrophil count in /L，lymphocyte count in /L，Platelet count in /L，Creatinine in μmol/L, Bilirubin in mg/dL, ALP in U/L, γ-glutamyl transpeptidase in U/L，AST in U/L, ALT in U/L, Albumin in g/dL, triglycerides in mmol/L, total cholesterol in mmol/L，cardiac troponin I in ng/mL， myoglobin in ng/mL， brain natriuretic peptide precursors in pg/mL， lactate dehydrogenase in U/L, Creatine Kinase in U/L).
Radiological findings
Time frame: 1-3years
Radiological findings such as chest computed tomography will be assessed.
pulmonary function
Time frame: 1-3years
pulmonary function tests will be assessed.
Heart function
Time frame: 1-3years
electrocardiogram including arrhythmia,ST-T change and conduction block will be assessed.（they have no Units）
Abdominal ultrasound
Time frame: 1-3years
Abdominal ultrasound will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prognosis and Sequelae, run by Tongji Hospital 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 1 inclusion and 1 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 18 Mar 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms and signs (time frame: 1-3years). 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 18 Mar 2024.