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

NCT05669248 | Unknown DMC

• 1 other identifier: Qilu-20221224-pang
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Immunosuppression

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

mid covid-19 patients DIAGNOSTIC_TEST

Collect the patient's whole blood for testing

mid covid-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant is diagnosed with symptomatic COVID-19 by a positive PCR for SARS-CoV-2 or antigen quicktest.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5ml blood sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jiaojiao Pang, Dr

CONTACT

+8618560089129; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: December 30, 2022
• Study Start: January 3, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 28, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)