A Follow-up Study of Immune Dysregulation in Patients With COVID-19

Recruiting

• Conditions: COVID-19; Immunosuppression
• Interventions: Diagnostic Test: mid covid-19 patients

• Registration Number: NCT05669248
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

In order to detect the immunosuppression status of COVID-19 patients, this study collected blood samples of COVID-19 patients on the 10th, 20th and 30th days after the onset of symptoms, and detected the proinflammatory, anti-inflammatory factors，immunosuppressive marker，immune cells in the blood samples to evaluate the immunosuppression status of COVID-19 patients.

Detailed Description

After SARS-CoV-2 infection, the patient's immune system is overactivated. While the immune cells release a large number of proinflammatory factors, anti-inflammatory response starts at the same time. Anti-inflammatory factors such as IL-4, IL-10, and IL-37 will be compensated to resist the release of proinflammatory factors and prevent the further development of systemic inflammatory response. However, when the anti-inflammatory factor is excessively released, it will cause compensatory response syndrome, leading to immunosuppression. Whether the level of anti-inflammatory factors continues to rise, and whether it will lead to the persistence of later immunosuppression is unknown. Therefore, this study intends to recruit COVID-19 patients, detect the pro-inflammatory and anti-inflammatory factors，immunosuppressive marker，immune cells in 10 days, 20days, and 30days after the symptoms appear, and evaluate the immunosuppression status of patients with COVID-19

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Study First Posted: 2022-12-30
• Study Start: 2023-01-03
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.
2. Study participant is 18 years of age or older

Exclusion Criteria

1. Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
2. Pregnancy or breastfeeding
3. Patients receiving chemotherapy or other cancer treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mid covid-19 patients	mid covid-19 patients	Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest and meet the standard of mild COVID-19

Primary Outcome Measures

Name	Time	Method
The concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、IFN-γ、TNF-α 、VEGF, etc.) in peripheral blood.	10, 20, 30days
The concentration of immunosuppression makers(HLA-DR, PD-1, TIM-3,etc.) in peripheral blood.	10, 20, 30days
The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood.	10, 20, 30days

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China