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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965843
• Other study ID #: 2023IITXG01
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Ke Qiu, MD.
• Phone: +86 18523571923
• Email: 535424396[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Chronic Liver Disease
• Healthy
• Liver Diseases
• Malignant Tumor

Intervention

Other:
• underling 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days
Secondary	Severe disease in patients with underline disease after Covid-19 infection.	Severe disease include severe Covid-19 and/or progression of underlying disease.	48weeks