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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03102-37 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Fonds IMMUNOV | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to describe the immunological and virological response of patients infected with CoV-2-SARS and presenting an asymptomatic or mildly symptomatic form, in particular the innate and adaptive response as well as the virological clearance kinetics.
The research hypothesis is that patients with an ambulatory form of SARS-CoV-2 infection, whether asymptomatic or mildly symptomatic, are able to mount an innate and adaptive immunological response capable of rapidly clearing the virus, in contrast to severe forms in which an early deficit of type 1 IFN response has been demonstrated, possibly responsible for a defect in the control of viral replication in the blood.
A new coronavirus (SARS-CoV-2) was identified in December 2019 in the Wuhan region of China and is currently causing a global pandemic.
The disease, named COVID-19, causes an influenza syndrome associated with respiratory signs, but there are also asymptomatic and pauci-symptomatic forms. Approximately 2 to 3% of patients, primarily patients with pre-existing chronic diseases and the elderly, develop a very severe form responsible for an acute respiratory distress syndrome (ARDS) that can lead to death.
It has been shown that patients with a severe and critical form had an impaired type 1 interferon response, with decreased plasma levels of IFN-alpha2 in the most severe patients compared to hospitalized patients with a moderate form, and undetectable levels of IFN-beta. This lack of type 1 IFN response was associated with greater viral persistence in the blood and an exaggerated inflammatory response mediated primarily by the NF-kB pathway.
Almost all studies published to date on immune system disruption during CoV-2-SARS infection included mainly hospitalized patients requiring oxygen therapy due to their severity, assessed at the time of clinical worsening.
Thus, there is no or little data on immunological response profiles, particularly on type 1 IFN response but also on other aspects of the immunological response (adaptive cellular and humoral immunity), and its relationship with viral clearance kinetics during ambulatory forms of SARS-CoV-2 infection, whereas these forms represent more than 95% of the clinical forms.
The asymptomatic and pauci-symptomatic forms managed on an outpatient basis represent the most common form of CoV-2-SARS infection, with a favourable outcome in almost all cases.
A better description and understanding of the immunological profile, including type 1 IFN response and viral clearance kinetics in saliva, blood and feces, during asymptomatic and mild clinical forms will allow the identification of the major players in the immune response against SARS-CoV-2, and thus better define the responses that are lacking in severe patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic | Experimental | 40 symptomatic patients to COVID-19 infection |
|
| Asymptomatic | Experimental | 40 asymptomatic patients to COVID-19 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood count | Diagnostic Test | Blood count at each visit |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Interferon response | Concentration of type I, type II and type III Interferon in peripheral blood | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunology : cytokines | Concentration of IL-6, TNF-alpha, IL-8, calprotectin in peripheral blood | Up to 90 days |
| Immunology : cell population | Proportions of monocytes, B cells and T cells in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Solen KERNEIS, Doctor | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | Île-de-France Region | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31978945 | Background | Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. | |
| 32105632 |
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| Blood collection |
| Diagnostic Test |
Blood collection to understanding of the immunological profile at each visit |
|
| Nasopharyngeal swab | Diagnostic Test | Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15 |
|
| Saliva samples | Diagnostic Test | Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion) |
|
| Faeces samples | Diagnostic Test | Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90 |
|
| Genetic blood collection | Genetic | Collection to further research at each visit |
|
| Data collection | Other | Demographics, symptoms, biological constants |
|
| Up to 90 days |
| Immunology : proteins | Concentration of anaphylatoxins C3a and C5a in peripheral blood | Up to 90 days |
| Immunology : pathways | Screening for genetic mutations involved in the interferon pathway | Up to 90 days |
| Immunology : antibody response | Concentration of antibodies directed against spike protein and nucleocapsids | Up to 90 days |
| Virology : Nasopharyngeal Viral clearance kinetics | Viral clearance kinetics in nasopharyngeal samples | Up to 90 days |
| Virology : Saliva Viral clearance kinetics | Viral clearance kinetics in saliva | Up to 90 days |
| Virology : faeces viral clearance kinetics | Viral clearance kinetics in faeces | Up to 90 days |
| Virology : peripheral blood viral clearance kinetics | Viral clearance kinetics in peripheral blood | Up to 90 days |
| Virology : sequencing | Analysis of virus mutations, especially of the gene encoding spike protein | Up to 90 days |
| Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. |
| 32661059 | Background | Hadjadj J, Yatim N, Barnabei L, Corneau A, Boussier J, Smith N, Pere H, Charbit B, Bondet V, Chenevier-Gobeaux C, Breillat P, Carlier N, Gauzit R, Morbieu C, Pene F, Marin N, Roche N, Szwebel TA, Merkling SH, Treluyer JM, Veyer D, Mouthon L, Blanc C, Tharaux PL, Rozenberg F, Fischer A, Duffy D, Rieux-Laucat F, Kerneis S, Terrier B. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients. Science. 2020 Aug 7;369(6504):718-724. doi: 10.1126/science.abc6027. Epub 2020 Jul 13. |
| 32717743 | Background | Lucas C, Wong P, Klein J, Castro TBR, Silva J, Sundaram M, Ellingson MK, Mao T, Oh JE, Israelow B, Takahashi T, Tokuyama M, Lu P, Venkataraman A, Park A, Mohanty S, Wang H, Wyllie AL, Vogels CBF, Earnest R, Lapidus S, Ott IM, Moore AJ, Muenker MC, Fournier JB, Campbell M, Odio CD, Casanovas-Massana A; Yale IMPACT Team; Herbst R, Shaw AC, Medzhitov R, Schulz WL, Grubaugh ND, Dela Cruz C, Farhadian S, Ko AI, Omer SB, Iwasaki A. Longitudinal analyses reveal immunological misfiring in severe COVID-19. Nature. 2020 Aug;584(7821):463-469. doi: 10.1038/s41586-020-2588-y. Epub 2020 Jul 27. |
| 37795693 | Result | Lingas G, Planas D, Pere H, Porrot F, Guivel-Benhassine F, Staropoli I, Duffy D, Chapuis N, Gobeaux C, Veyer D, Delaugerre C, Le Goff J, Getten P, Hadjadj J, Bellino A, Parfait B, Treluyer JM, Schwartz O, Guedj J, Kerneis S, Terrier B. Neutralizing Antibody Levels as a Correlate of Protection Against SARS-CoV-2 Infection: A Modeling Analysis. Clin Pharmacol Ther. 2024 Jan;115(1):86-94. doi: 10.1002/cpt.3069. Epub 2023 Oct 20. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| 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 |
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| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D001800 | Blood Specimen Collection |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D013048 | Specimen Handling |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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