T Cell DeficiencyNCT04470323
Functional Exhaustion of T Cells in COVID19 Patients
An observational study of T Cell Deficiency, run by Assiut University at 1 site in Egypt.
Trial summary
The primary end-point of our prospective, observational study is to count T cells in patients with laboratory-confirmed COVID-19 and healthy controls. In addition, the expression of T cell exhaustion marker was measured in COVID-19 cases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- T Cell Deficiency
- What is being tested?
- Flow cytometry
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2020to Nov 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients admitted to Assiut university Hospitals diagnosed as COVID-19 positive patients by PCR.
Who may be able to join
- Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed consent.
Who cannot join
- no exclusion criteriae
Trial locations and contacts
1 site in 1 country.
About this study
The primary end-point of our prospective, observational study is to count T cells in patients with laboratory-confirmed COVID-19 and healthy controls. In addition, the expression of T cell exhaustion marker was measured in COVID-19 cases.
Read the detailed description
COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed great threat to human health. T cells play a critical role in antiviral immunity but their numbers and functional state in COVID-19 patients remain largely unclear. The immune response against viral infections depends on the activation of cytotoxic T cells that can clear infection by killing virus-infected cells, so boosting the numbers and function of T cells in COVID-19 patients is critical for successful recovery. However, the factors which might cause the reduction in count, and the activation status of T cells in COVID-19 patients, remain uninvestigated. Thus demonstration of T cell exhaustion during COVID-19 infection suggest that more urgent, early intervention may be required in patients with low T lymphocyte counts.
- Conditions
- T Cell Deficiency
- Being tested
- Flow cytometry
- Medical subject headings
- Thymic aplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryDiagnostic test
Lymphocyte subsets in peripheral blood were assessed by staining 50 µl of blood sample with 5 µl of Fluoroisothiocyanate (FITC)-conjugated- PD-1, phycoerythrin (PE)-conjugated-CD8, peridinium-chlorophyll-protein (Per-CP)-conjugated-CD4, Peridinium-chlorophyll-protein (Per-CP)-conjugated anti-CD3 and allophycocyanin (APC) conjugated anti-CD28.
| Study group | Role | What they receive |
|---|---|---|
| COVID19 patients | Patients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. Receives: Diagnostic Test: Flow cytometry | |
| healthy volunteer | as negative control for each sample Receives: Diagnostic Test: Flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.
Detection of the percentage of CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.
Measured: Baseline
CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers.
Detection of the percentage of CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers .
Measured: Baseline
Detect PD-1 on CD8+ and CD4+ cells in COVID 19 patients and healthy volunteers .
Detection of the percentage of expression of PD-1 on CD8+ and CD4+ cells in COVID 19 patient and healthy volunteers.
Measured: Baseline
Detect CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers.
Detection of the frequency of CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start22 Jul 2020
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for T Cell DeficiencyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470323
- Sponsor's protocol ID
- T cells
- Status last verified
- Aug 2020
- First submitted
- 12 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diao B, Wang C, Tan Y, Chen X, Liu Y, Ning L, Chen L, Li M, Liu Y, Wang G, Yuan Z, Feng Z, Zhang Y, Wu Y, Chen Y. Reduction and Functional Exhaustion of T Cells in Patients With Coronavirus Disease 2019 (COVID-19). Front Immunol. 2020 May 1;11:827. doi: 10.3389/fimmu.2020.00827. eCollection 2020.
PubMed 32425950Li CK, Wu H, Yan H, Ma S, Wang L, Zhang M, Tang X, Temperton NJ, Weiss RA, Brenchley JM, Douek DC, Mongkolsapaya J, Tran BH, Lin CL, Screaton GR, Hou JL, McMichael AJ, Xu XN. T cell responses to whole SARS coronavirus in humans. J Immunol. 2008 Oct 15;181(8):5490-500. doi: 10.4049/jimmunol.181.8.5490.
PubMed 18832706Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
PubMed 32007143Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exhaustion of T Cells in COVID19 Patients
- ClinicalTrials.gov ID
- NCT04470323
- Acronym / sponsor ID
- T cells
- Conditions
- T Cell Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 14 Jul 2020 (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.
The primary end-point of our prospective, observational study is to count T cells in patients with laboratory-confirmed COVID-19 and healthy controls. In addition, the expression of T cell exhaustion marker was measured in COVID-19 cases.
Detailed description
COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has posed great threat to human health. T cells play a critical role in antiviral immunity but their numbers and functional state in COVID-19 patients remain largely unclear. The immune response against viral infections depends on the activation of cytotoxic T cells that can clear infection by killing virus-infected cells, so boosting the numbers and function of T cells in COVID-19 patients is critical for successful recovery. However, the factors which might cause the reduction in count, and the activation status of T cells in COVID-19 patients, remain uninvestigated. Thus demonstration of T cell exhaustion during COVID-19 infection suggest that more urgent, early intervention may be required in patients with low T lymphocyte counts.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 patients | – | Diagnostic Test: Flow cytometryPatients admitted to Assiut university Hospitals diagnosed as COVID19 positive patients by PCR. |
| healthy volunteer | – | Diagnostic Test: Flow cytometryas negative control for each sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Assiut university Hospitals diagnosed as COVID-19 positive patients by PCR.
Key inclusion criteria (1 listed)
- Diagnosis of Covid-19 test positive; hospitalized subjects; both sexes; given informed consent.
Key exclusion criteria (1 listed)
- no exclusion criteriae
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 |
|---|---|---|
| Flow cytometryLymphocyte subsets in peripheral blood were assessed by staining 50 µl of blood sample with 5 µl of Fluoroisothiocyanate (FITC)-conjugated- PD-1, phycoerythrin (PE)-conjugated-CD8, peridinium-chlorophyll-protein (Per-CP)-conjugated-CD4, Peridinium-chlorophyll-protein (Per-CP)-conjugated anti-CD3 and allophycocyanin (APC) conjugated anti-CD28. | Diagnostic test | COVID19 patients, healthy volunteer |
Primary outcome
CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.
Time frame: Baseline
Detection of the percentage of CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers.
CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers.
Time frame: Baseline
Detection of the percentage of CD8+ (T-cytotoxic cells) in COVID 19 patients and healthy volunteers .
Detect PD-1 on CD8+ and CD4+ cells in COVID 19 patients and healthy volunteers .
Time frame: Baseline
Detection of the percentage of expression of PD-1 on CD8+ and CD4+ cells in COVID 19 patient and healthy volunteers.
Detect CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers.
Time frame: Baseline
Detection of the frequency of CD28+ and CD3+ cells in COVID 19 patients and healthy volunteers .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Background: PubMed 32425950Diao B, Wang C, Tan Y, Chen X, Liu Y, Ning L, Chen L, Li M, Liu Y, Wang G, Yuan Z, Feng Z, Zhang Y, Wu Y, Chen Y. Reduction and Functional Exhaustion of T Cells in Patients With Coronavirus Disease 2019 (COVID-19). Front Immunol. 2020 May 1;11:827. doi: 10.3389/fimmu.2020.00827. eCollection 2020.
- Background: PubMed 18832706Li CK, Wu H, Yan H, Ma S, Wang L, Zhang M, Tang X, Temperton NJ, Weiss RA, Brenchley JM, Douek DC, Mongkolsapaya J, Tran BH, Lin CL, Screaton GR, Hou JL, McMichael AJ, Xu XN. T cell responses to whole SARS coronavirus in humans. J Immunol. 2008 Oct 15;181(8):5490-500. doi: 10.4049/jimmunol.181.8.5490.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 32007143Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- 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 T Cell Deficiency, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 6 Aug 2020. 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 Egypt. 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 Hebatallah Hassan, Lecturer (01022182086, heba.ismailhassan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4+ (T-helper cells) in COVID 19 patients and healthy volunteers. (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04470323, which also lists 5 linked publications.
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 6 Aug 2020.