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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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COVID-19, Immunosuppression

Intervention / Treatment
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* Diagnostic Test: mid covid-19 patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest. Study participant is 18 years of age or older Exclusion Criteria: Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy Pregnancy or breastfeeding Patients receiving chemotherapy or other cancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mid covid-19 patients<br>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 | Diagnostic Test: mid covid-19 patients<br>* Collect the patient's whole blood for testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |