Study on Immune Status of Patients With COVID-19

January 10, 2023 updated by: Qilu Hospital of Shandong University
This study is a prospective cohort study aimed to clarify the continuous immune state changes of patients with COVID-19. Investigators include the patients admitted to the hospital within one week after the onset of COVID-19. 10ml of patients' blood was collected day 1, day 7, day 14 , and day 20 after the patients admitted to the hospital. The blood inflammatory factors, immune related molecules, and immune cells were detected to determine the changes of patients' immune status. The impact of immune status changes on prognosis and quality of life in later follow-up period was evaluated by various questionnaires and evaluation scales.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 interleukin 4 (IL-4), interleukin 10 (IL-10) and interleukin 37 (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 patients infected with novel coronavirus to enter the hospital within one week of onset, and collect 10ml of patients' blood on the first, seventh, fourteenth and twentieth day after the patients feel the hospital feeling, respectively, to detect the blood inflammatory factors, immune related molecules and immune cells, and determine the changes of patients' immune status. The patients were followed up for 2 and 6 months after arriving at the hospital to conduct self-reported symptom questionnaire, health related quality of life (HRQoL) questionnaire, Hospital Anxiety and Depression Scale (HADS), and other questionnaires and scales to assess the impact of changes in the patient's immunological status on the prognosis and later quality of life.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250112
        • Recruiting
        • Qilu Hospital Of Shandong University
        • Principal Investigator:
          • jiaojiao Pang, Professor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participant is diagnosed with symptomatic COVID-19 by a positive PCR or rapid antigen detection for SARS-CoV-2 and with treatment in hospital

Description

Inclusion Criteria:

  1. Patients diagnosed as novel coronavirus infection by PCR or antigen rapid detection for the first time
  2. Patients hospitalized within one week after the occurrence of clinical symptoms related to novel coronavirus infection (fever, cough, shortness of breath or dyspnea, fatigue, headache, muscle or body pain, sore throat, nasal congestion or runny nose, chills, nausea, vomiting, diarrhea, mental state changes)
  3. Age over 18, gender unlimited

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
covid-19 Inpatients
Participant is diagnosed with symptomatic COVID-19 by a positive polymerase chain reaction(PCR) or rapid antigen detection for SARS-CoV-2 and with treatment in hospital
Diagnostic test: hospitalized patient
Collect the patient's whole blood for testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、 interferon-gamma（IFN-γ）、tumour necrosis factor alpha(TNF-α) 、vascular endothelial growth factor（VEGF）, etc.) in peripheral blood.
Time Frame: 1, 7, 14, 20 days after the patient arrives at the hospital
1, 7, 14, 20 days after the patient arrives at the hospital
Changes in the concentration of immunosuppression makers(HLA-DR, Programmed Cell Death Ligand 1 （PD-1）, T cell immunoglobulin and mucin domain 3（TIM-3）,etc.) in peripheral blood.
Time Frame: 1, 7, 14, 20 days after the patient arrives at the hospital
1, 7, 14, 20 days after the patient arrives at the hospital
Changes in the number of immune cells(Th1/Th2 cell, Treg cell, Myeloid-derived suppressor cells,etc.) in peripheral blood.
Time Frame: 1, 7, 14, 20 days after the patient arrives at the hospital
1, 7, 14, 20 days after the patient arrives at the hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-reported symptom
Time Frame: 2，6 months after the patient arrives at the hospital
2，6 months after the patient arrives at the hospital
health related quality of life (HRQoL) questionnaire,
Time Frame: 2，6 months after the patient arrives at the hospital
There are five dimensions, each with a minimum value of 1 and a maximum value of 3, and the higher score mean a worse outcome
2，6 months after the patient arrives at the hospital
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 2，6 months after the patient arrives at the hospital
There are two dimensions, each with a minimum value of 0 and a maximum value of 21，and higher score mean a worse outcome
2，6 months after the patient arrives at the hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 5, 2023

Primary Completion (Anticipated)

November 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qilu-20230105-pang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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