Chronic Liver DiseaseNCT05965843
Intervention, Prognosis and Mechanism of Covid-19 Infection in Patients With Underlying Diseases
An observational study of Chronic Liver Disease and Malignant Tumor, run by The Second Affiliated Hospital of Chongqing Medical University.
Trial summary
The goal of this observational study is to explore the influence of Covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Liver Disease, Malignant Tumor, Autoimmune Diseases
- What is being tested?
- underling disease
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population was population with underling disease from single-centre and medical staff from multiple centers in Chongqing.
Who may be able to join
- Sign the informed consent form before enrollment, and be able to complete the research according to the requirements of the research protocol.
- Enrolled patients need to have basic diseases, including chronic liver disease, chronic kidney disease, chronic lung disease, solid tumors, AIDS, rheumatic immune diseases, diabetes, etc.
- When entering the group, patients with new crowns need to be confirmed by evidence of a positive test for new coronavirus nucleic acid (CT value <35) or a positive test for new coronavirus antigen.
Who cannot join
- Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use medical devices.
- Positive pregnancy test during lactation or screening period.
- Subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on the Intervention, Prognosis and Mechanism of Novel Coronavirus Infection in Patients With Underlying Diseases
The goal of this observational study is to explore the influence of Covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff.
The main questions it aims to answer are:
Read more
- The clinical characteristics of vulnerable population after Covid-19 infection.
- Risk factors for severe illness in vulnerable groups after infection with the Covid-19.
- The impact of Covid-19 infection on the progression of underlying diseases.
Information of participants will be collected such as gender, age, underlying diseases, medication status, vaccination status, clinical and biochemical indicators.
Researchers will compare the mild and severe outcomes after Covid-19 infection to identify the "truly vulnerable" population and explore the potential mechanism and intervention for these population.
- Conditions
- Chronic Liver Disease, Malignant Tumor, Autoimmune Diseases, Healthy
- Being tested
- underling disease
- Medical subject headings
- Neoplasms, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
underling diseaseOther
Nowadays Covid-19 virus has become milder than before however severe outcomes still happen in people with underlying diseases after infection.
For example, previous research indicated cirrhosis was an independent predictor for COVID-19 mortality.
More efforts shoud be make to explore the association between underlying diseases and severe COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| chronic liver disease | No additional interventions for this group. Receives: Other: underling disease | |
| malignant tumor | No additional interventions for this group. Receives: Other: underling disease | |
| autoimmune disease | No additional interventions for this group. Receives: Other: underling disease | |
| medical staff | No additional interventions for this group. Receives: Other: underling disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality in patients with underline disease after Covid-19 infection.
All-cause mortality is a measure of the total number of deaths from any cause.
Measured: 30 days
Secondary outcomes (1)
Severe disease in patients with underline disease after Covid-19 infection.
Severe disease include severe Covid-19 and/or progression of underlying disease.
Measured: 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peng Hu, PhD., Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965843
- Sponsor's protocol ID
- 2023IITXG01
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Intervention, Prognosis and Mechanism of Novel Coronavirus Infection in Patients With Underlying Diseases
- ClinicalTrials.gov ID
- NCT05965843
- Acronym / sponsor ID
- 2023IITXG01
- Conditions
- Chronic Liver Disease, Malignant Tumor, Autoimmune Diseases, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jul 2023 (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 goal of this observational study is to explore the influence of Covid-19 infection and risk factors of severe outcomes in vulnerable population including patients with chronic liver disease, malignant tumor, autoimmune disease, medical staff.
The main questions it aims to answer are:
- The clinical characteristics of vulnerable population after Covid-19 infection.
- Risk factors for severe illness in vulnerable groups after infection with the Covid-19.
- The impact of Covid-19 infection on the progression of underlying diseases.
Information of participants will be collected such as gender, age, underlying diseases, medication status, vaccination status, clinical and biochemical indicators.
Researchers will compare the mild and severe outcomes after Covid-19 infection to identify the "truly vulnerable" population and explore the potential mechanism and intervention for these population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| chronic liver disease | – | Other: underling diseaseNo additional interventions for this group. |
| malignant tumor | – | Other: underling diseaseNo additional interventions for this group. |
| autoimmune disease | – | Other: underling diseaseNo additional interventions for this group. |
| medical staff | – | Other: underling diseaseNo additional interventions for this group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population was population with underling disease from single-centre and medical staff from multiple centers in Chongqing.
Key inclusion criteria (3 listed)
- Sign the informed consent form before enrollment, and be able to complete the research according to the requirements of the research protocol.
- Enrolled patients need to have basic diseases, including chronic liver disease, chronic kidney disease, chronic lung disease, solid tumors, AIDS, rheumatic immune diseases, diabetes, etc.
- When entering the group, patients with new crowns need to be confirmed by evidence of a positive test for new coronavirus nucleic acid (CT value <35) or a positive test for new coronavirus antigen.
Key exclusion criteria (3 listed)
- Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use medical devices.
- Positive pregnancy test during lactation or screening period.
- Subjects who, in the investigator's opinion, have other factors that are not suitable for participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| underling diseaseNowadays Covid-19 virus has become milder than before however severe outcomes still happen in people with underlying diseases after infection. For example, previous research indicated cirrhosis was an independent predictor for COVID-19 mortality. More efforts shoud be make to explore the association between underlying diseases and severe COVID-19. | Other | autoimmune disease, chronic liver disease, malignant tumor, medical staff |
Primary outcome
All-cause mortality in patients with underline disease after Covid-19 infection.
Time frame: 30 days
All-cause mortality is a measure of the total number of deaths from any cause.
1 secondary outcome
Severe disease in patients with underline disease after Covid-19 infection.
Time frame: 48weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- 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.
Peng Hu, PhD. study director
The Second Affiliated Hospital of Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Malignant Tumor, run by The Second Affiliated Hospital of Chongqing Medical University.
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 3 inclusion and 3 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ke Qiu, MD. (+86 18523571923, 535424396@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality in patients with underline disease after Covid-19 infection. (time frame: 30 days). 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 3 Aug 2023.