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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05669248
Collaborator
(none)
200
1
11.9
16.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: mid 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, 17days, and 24days after the symptoms appear, and evaluate the immunosuppression status of patients with COVID-19

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Follow-up Study of Immune Dysregulation in Patients With COVID-19
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Diagnostic Test: mid covid-19 patients
Collect the patient's whole blood for testing

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. The concentration of immunosuppression makers(HLA-DR, PD-1, TIM-3,etc.) in peripheral blood. [10, 20, 30days]

  3. The number of immune cells(Th1/Th2 cell, Treg cell, MDSCs,etc.) in peripheral blood. [10, 20, 30days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qilu Hospital of Shandong University Jinan Shandong China 250012

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05669248
Other Study ID Numbers:
  • Qilu-20221224-pang
First Posted:
Dec 30, 2022
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023