COVID-19NCT05682573
Study on Immune Status of Patients With COVID-19
An observational study of COVID-19 and Immunity, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Immunity, Life Quality
- What is being tested?
- hospitalized patient
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients diagnosed as novel coronavirus infection by PCR or antigen rapid detection for the first time
- 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)
- Age over 18, gender unlimited
Who cannot join
- Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
- Patients with severe autoimmune diseases
- Patients receiving chemotherapy or cancer treatment
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250112
yuguo Chen, Dr, +8618678812777, chen919085@126.com
jiaojiao Pang, Professor
About this study
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.
Read the 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.
- Conditions
- COVID-19, Immunity, Life Quality
- Being tested
- hospitalized patient
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospitalized patientDiagnostic test
Collect the patient's whole blood for testing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: hospitalized patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1, 7, 14, 20 days after the patient arrives at the hospital
Secondary outcomes (3)
self-reported symptom
Measured: 2，6 months after the patient arrives at the hospital
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
Measured: 2，6 months after the patient arrives at the hospital
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
Measured: 2，6 months after the patient arrives at the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start5 Jan 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682573
- Sponsor's protocol ID
- Qilu-20230105-pang
- Status last verified
- Jan 2023
- First submitted
- 7 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Immune Status of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05682573
- Acronym / sponsor ID
- Qilu-20230105-pang
- Conditions
- COVID-19, Immunity, Life Quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| covid-19 Inpatients | – | Diagnostic Test: hospitalized patientParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients diagnosed as novel coronavirus infection by PCR or antigen rapid detection for the first time
- 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)
- Age over 18, gender unlimited
Key exclusion criteria (4 listed)
- Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
- Patients with severe autoimmune diseases
- Patients receiving chemotherapy or cancer treatment
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hospitalized patientCollect the patient's whole blood for testing | Diagnostic test | covid-19 Inpatients |
Primary outcome
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
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
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
3 secondary outcomes
self-reported symptom
Time frame: 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
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2，6 months after the patient arrives at the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Immunity, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuguo Chen, Dr (+8618678812777, chen919085@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.