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| Name | Class |
|---|---|
| Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | OTHER |
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This is an open-label, prospective observational study in people 18 years of age and older designed to track changes in the dynamics of the respiratory and peripheral blood immune response in people infected with influenza virus and new coronaviruses, and to resolve the characteristics of the virus-induced natural immune response.
The clinical trial enrolls 130 subjects aged 18 years and older with ≥3 months between their last COVID-19/influenza vaccination or respiratory virus infection. Mucosal and peripheral blood samples will be collected from COVID-19-infected and influenza-infected patients during the preinfection, infection, and recovery periods, and cytokines, immune cell typing, immune cell transcription, and specific antibody levels will be examined in these patients. Levels of cytokines, immune cell typing, immune cell gene transcription, specific antibodies, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:COVID-19 infected persons | Inclusion Criteria:
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| Cohort 2:Influenza virus infected persons | Inclusion Criteria:
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| Cohort 3:Healthy Volunteers | Inclusion Criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal swab/Nasopharyngeal swab/Blood sample collection | Other | Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in mucosal sample as calculated by Illumina NGS platform. | Measuring method: Single-cell RNA sequencing. Metric/method of measurement: cell frequency | From the enrollment to the end of the visit on the 28th ± 3rd day |
| The Ct value of SARS-CoV-2 N gene, Influenza A HA gene and Influenza B PA gene in mucosal sample as assessed by Real-Time RT-PCR | Measuring method: Real-Time RT-PCR Metric/method of measurement: Ct value | From the enrollment to the end of the visit on the 28th ± 3rd day |
| The SARS-CoV-2, Influenza A and Influenza B-specific IgG titer in serum sample assessed by ELISA. | Measuring method: ELISA Metric/method of measurement: antibody titer | From the enrollment to the end of the visit on the 28th ± 3rd day |
| The level of IL-1β, IL-6, IFN-gamma, MCP-1, CXCL9, CXCL10, MCP-1 and TNF-alpha in serum sample assessed by Luminex. | Measuring method: Luminex Metric/method of measurement: concentration | From the enrollment to the end of the visit on the 28th ± 3rd day |
| The transcriptome profiles of peripheral blood mononuclear cell assessed by RNA-sequencing Measuring method: RNA-sequencing | Metric/method of measurement: gene count | From the enrollment to the end of the visit on the 28th ± 3rd day |
| The frequency of DC, monocyte, NK cell, macrophage cell, B cell and T cell in blood sample as assessed by the flow cytometer | Measuring method: flow cytometer Metric/method of measurement: cell frequency |
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Inclusion Criteria:
Exclusion Criteria:
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This study is planned to include 50 patients infected with novel coronavirus, 50 patients infected with influenza virus and 30 healthy volunteers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianying Huang | Contact | 02167811702 | znyylcsy@126.com | |
| Jian Xia | Contact | 02167812521 | jianxia@whu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34174187 | Result | Wimmers F, Donato M, Kuo A, Ashuach T, Gupta S, Li C, Dvorak M, Foecke MH, Chang SE, Hagan T, De Jong SE, Maecker HT, van der Most R, Cheung P, Cortese M, Bosinger SE, Davis M, Rouphael N, Subramaniam S, Yosef N, Utz PJ, Khatri P, Pulendran B. The single-cell epigenomic and transcriptional landscape of immunity to influenza vaccination. Cell. 2021 Jul 22;184(15):3915-3935.e21. doi: 10.1016/j.cell.2021.05.039. Epub 2021 Jun 25. | |
| 33171100 |
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Nasal mucosa/Nasopharyngeal mucosa/Blood
| Nasal swab/Nasopharyngeal swab/Blood draw | Other | Visit 1/2/3:Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing |
|
| Nasal swab/Nasopharyngeal swab/Blood draw | Other | Visit 1/2/3:Collect nasal or nasopharyngeal swab samples, 15ml anticoagulant samples and 3ml procoagulant samples, as well as 2ml blood samples for blood routine testing and C-reactive protein testing |
|
| From the enrollment to the end of the visit on the 28th ± 3rd day |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430000 | China |
|
| Result |
| Su Y, Chen D, Yuan D, Lausted C, Choi J, Dai CL, Voillet V, Duvvuri VR, Scherler K, Troisch P, Baloni P, Qin G, Smith B, Kornilov SA, Rostomily C, Xu A, Li J, Dong S, Rothchild A, Zhou J, Murray K, Edmark R, Hong S, Heath JE, Earls J, Zhang R, Xie J, Li S, Roper R, Jones L, Zhou Y, Rowen L, Liu R, Mackay S, O'Mahony DS, Dale CR, Wallick JA, Algren HA, Zager MA; ISB-Swedish COVID19 Biobanking Unit; Wei W, Price ND, Huang S, Subramanian N, Wang K, Magis AT, Hadlock JJ, Hood L, Aderem A, Bluestone JA, Lanier LL, Greenberg PD, Gottardo R, Davis MM, Goldman JD, Heath JR. Multi-Omics Resolves a Sharp Disease-State Shift between Mild and Moderate COVID-19. Cell. 2020 Dec 10;183(6):1479-1495.e20. doi: 10.1016/j.cell.2020.10.037. Epub 2020 Oct 28. |
| 33789928 | Result | Clementi N, Ghosh S, De Santis M, Castelli M, Criscuolo E, Zanoni I, Clementi M, Mancini N. Viral Respiratory Pathogens and Lung Injury. Clin Microbiol Rev. 2021 Mar 31;34(3):e00103-20. doi: 10.1128/CMR.00103-20. Print 2021 Jun 16. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
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