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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autoimmune Diseases; Healthy; Chronic Liver Disease; Malignant Tumor
• Intervention / Treatment: Other: underling disease

• Study Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: Ke Qiu, MD.; Phone Number: +86 18523571923; Email: 535424396@qq.com
• Study Contact Backup: Name: Peng Hu, PhD.; Phone Number: +86 13608338064; Email: hp_cq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population was population with underling disease from single-centre and medical staff from multiple centers in Chongqing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic liver disease; No additional interventions for this group.	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.
malignant tumor; No additional interventions for this group.	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.
autoimmune disease; No additional interventions for this group.	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.
medical staff; No additional interventions for this group.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe disease in patients with underline disease after Covid-19 infection.	Severe disease include severe Covid-19 and/or progression of underlying disease.	48weeks

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Director: Peng Hu, PhD., The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Liver Diseases; Autoimmune Diseases
• Other Study ID Numbers: 2023IITXG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No