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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05682573
Other study ID # Qilu-20230105-pang
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2023
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source Qilu Hospital of Shandong University
Contact yuguo Chen, Dr
Phone +8618678812777
Email chen919085@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
hospitalized patient
Collect the patient's whole blood for testing

Locations

Country Name City State
China Qilu Hospital of Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the concentration of inflammatory markers (IL-1ß?IL-2? IL-2R ?IL-4 ? IL-6 ? IL-8? IL-10 ? interferon-gamma(IFN-?)?tumour necrosis factor alpha(TNF-a) ?vascular endothelial growth factor(VEGF), etc.) in peripheral blood. 1, 7, 14, 20 days after the patient arrives at the hospital
Primary 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. 1, 7, 14, 20 days after the patient arrives at the hospital
Primary Changes in the number of immune cells(Th1/Th2 cell, Treg cell, Myeloid-derived suppressor cells,etc.) in peripheral blood. 1, 7, 14, 20 days after the patient arrives at the hospital
Secondary self-reported symptom 2,6 months after the patient arrives at the hospital
Secondary health related quality of life (HRQoL) questionnaire, 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
Secondary Hospital Anxiety and Depression Scale (HADS) 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
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