Immune Response Following COVID-19 in Hemodialysis Patients

COVID-19 Clinical Trial

— IMMUNOVIDIAL  

Official title:

Evaluation of the Cytokine 's Profile Following SarsCov 2 Infection (COVID-19) in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05307601
• Other study ID #: 2020-A01426-33
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2022
• Source: AURA Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 30, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Cytokine Release Syndrome
• Cytokine Storm
• Dialysis; Complications

Locations

Country	Name	City	State
France	AURA Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
AURA Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. Review. — View 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 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the cytokine profile during the early phase of COVID-19	Measurement of 29 cytokines by Luminex including type I and Type III Interferon	Measurement at Day 7 of COVID-19
Primary	Characterization of the cytokine profile during the inflammatory phase of COVID-19	Measurement of 29 cytokines by Luminex including type I and Type III Interferon	Measurement at Day 14 of COVID-19]