IMMUNOVIDIAL: Immune Response Following COVID-19 in Hemodialysis Patients
Study Details
Study Description
Brief Summary
Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19.
This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Inclusion criteria were (1) Adult (>18 years old) patient on HD > 6 months, and (2) infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan).
Severe forms of COVID-19 were defined as requiring oxygen therapy, admission in intensive care unit (ICU) or death
Primary end point :
- Characterization the cytokine's profile at the early (day 7) and inflammatory (day 14) phase of COViD-19 in HD patient
Secondary End points :
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Analyse the kinetic of the antiviral response (type I and III interferon ) between the early (day 7) and inflammatory (day 14) phase of COViD-19.
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Analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of COViD-19.
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Define an antiviral signature associated with severe form of COVID-19
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Define an anti inflammatory signature associated with severe form of COVID-19
Cytokine's profile is define by the measure of 28 cytokines by Luminex technology
Study Design
Outcome Measures
Primary Outcome Measures
- Characterization of the cytokine profile during the early phase of COVID-19 [Measurement at Day 7 of COVID-19]
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
- Characterization of the cytokine profile during the inflammatory phase of COVID-19 [Measurement at Day 14 of COVID-19]]
Measurement of 29 cytokines by Luminex including type I and Type III Interferon
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult (>18 years old) patient on HD > 6 months, and
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Infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan). The date of diagnosis was defined as the day when RT-PCR or CT-scan confirmed the diagnosis.
Exclusion Criteria:
- Inability to give consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AURA Paris | Paris | France | 75014 |
Sponsors and Collaborators
- AURA Paris
Investigators
- Principal Investigator: Maxime Touzot, MD, PhD, AURA Paris
Study Documents (Full-Text)
None provided.More Information
Publications
- Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.
- Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13. Review.
- Mutinelli-Szymanski P, Hude I, Merle E, Lombardi Y, Seris P, Abtahi M, Azeroual L, Bourgain C, Ensergueix G, Katerinis I, Kolko A, Kolta A, Maheas C, Mehrbanian S, Morel P, Ossman R, de Préneuf H, Roux A, Saltiel C, Vendé F, Verhoeven AS, Viron B, Laplanche S, Le Monnier A, Ridel C, Ureña-Torres P, Touzot M. Neutrophil:lymphocyte ratio predicts short-term outcome of COVID-19 in haemodialysis patients. Clin Kidney J. 2020 Nov 21;14(1):124-131. doi: 10.1093/ckj/sfaa194. eCollection 2021 Jan.
- Pedersen SF, Ho YC. SARS-CoV-2: a storm is raging. J Clin Invest. 2020 May 1;130(5):2202-2205. doi: 10.1172/JCI137647.
- 2020-A01426-33