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Trial Title:
Intervention, Prognosis and Mechanism of Covid-19 Infection in Patients With Underlying Diseases
NCT ID:
NCT05965843
Condition:
Chronic Liver Disease
Malignant Tumor
Autoimmune Diseases
Healthy
Conditions: Official terms:
Liver Diseases
Autoimmune Diseases
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
underling disease
Description:
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.
Arm group label:
autoimmune disease
Arm group label:
chronic liver disease
Arm group label:
malignant tumor
Arm group label:
medical staff
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. The clinical characteristics of vulnerable population after Covid-19 infection.
2. Risk factors for severe illness in vulnerable groups after infection with the
Covid-19.
3. 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.
Criteria for eligibility:
Study pop:
The target population was population with underling disease from single-centre and
medical staff from multiple centers in Chongqing.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Sign the informed consent form before enrollment, and be able to complete the
research according to the requirements of the research protocol.
2. 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.
3. 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.
Exclusion Criteria:
1. Participate in clinical trials of other investigational drugs or medical devices
within 3 months before screening, and take experimental drugs or use medical
devices.
2. Positive pregnancy test during lactation or screening period.
3. Subjects who, in the investigator's opinion, have other factors that are not
suitable for participating in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Start date:
August 2023
Completion date:
December 2024
Lead sponsor:
Agency:
The Second Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Source:
The Second Affiliated Hospital of Chongqing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965843
