Immune Response Following COVID-19 in Hemodialysis Patients

Completed

• Conditions: COVID-19; Cytokine Storm; Dialysis; Complications

• Registration Number: NCT05307601
• Lead Sponsor: AURA Paris

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

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-10-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AURA Paris; 🇫🇷 Paris, France