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

Not yet recruiting

• Conditions: Autoimmune Diseases; Chronic Liver Disease; Healthy; Malignant Tumor
• Interventions: Other: underling disease

• Registration Number: NCT05965843
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-07-28
• Study Start: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
malignant tumor	underling disease	No additional interventions for this group.
chronic liver disease	underling disease	No additional interventions for this group.
autoimmune disease	underling disease	No additional interventions for this group.
medical staff	underling disease	No additional interventions for this group.

Primary Outcome Measures

Name	Time	Method
All-cause mortality in patients with underline disease after Covid-19 infection.	30 days	All-cause mortality is a measure of the total number of deaths from any cause.

Secondary Outcome Measures

Name	Time	Method
Severe disease in patients with underline disease after Covid-19 infection.	48weeks	Severe disease include severe Covid-19 and/or progression of underlying disease.