Clinical trial NCT05307601: Immune Response Following COVID-19 in Hemodialysis Patients
Official title: Evaluation of the Cytokine 's Profile Following SarsCov 2 Infection (COVID-19) in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis; Complications
COVID-19
Cytokine Storm
Keywords: dialysis
cytokine
COVID-19
Lead sponsor: AURA Paris
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult HD patients from 2 main dialysis units of the AURA: AURA Paris Plaisance and Saint-Ouen

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

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 :

* 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.
* Analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of COViD-19.
* Define an antiviral signature associated with severe form of COVID-19
* 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

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years old) patient on HD \> 6 months, and
* 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

Primary outcomes:
measure: Characterization of the cytokine profile during the early phase of COVID-19
timeFrame: Measurement at Day 7 of COVID-19
measure: Characterization of the cytokine profile during the inflammatory phase of COVID-19
timeFrame: Measurement at Day 14 of COVID-19]
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: AURA Paris
Study officials:
affiliation: AURA Paris
name: Maxime Touzot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Preneuf H, Roux A, Saltiel C, Vende F, Verhoeven AS, Viron B, Laplanche S, Le Monnier A, Ridel C, Urena-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.
citation: 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.
citation: 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.
citation: 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.