Immune Response Following COVID-19 in Hemodialysis Patients

NCT ID: NCT05307601

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-30

Brief Summary

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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

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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

Conditions

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Dialysis; Complications COVID-19 Cytokine Storm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AURA Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxime Touzot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AURA Paris

Locations

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AURA Paris

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 33558835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18701615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32217835 (View on PubMed)

Other Identifiers

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2020-A01426-33

Identifier Type: -

Identifier Source: org_study_id

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