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Intervention, Prognosis and Mechanism of Covid-19 Infection in Patients With Underlying Diseases

Research on the Intervention, Prognosis and Mechanism of Novel Coronavirus Infection in Patients With Underlying Diseases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05965843
Enrollment
480
Registered
2023-07-28
Start date
2023-08-31
Completion date
2024-12-31
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Diseases, Chronic Liver Disease, Healthy, Malignant Tumor

Brief 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.

Interventions

OTHERunderling disease

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.

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality in patients with underline disease after Covid-19 infection.30 daysAll-cause mortality is a measure of the total number of deaths from any cause.

Secondary

MeasureTime frameDescription
Severe disease in patients with underline disease after Covid-19 infection.48weeksSevere disease include severe Covid-19 and/or progression of underlying disease.

Contacts

Primary ContactKe Qiu, MD.
535424396@qq.com+86 18523571923
Backup ContactPeng Hu, PhD.
hp_cq@163.com+86 13608338064

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026