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OpenTrials
Completed

NCT Number: NCT05307601

Immune Response Following COVID-19 in Hemodialysis Patients

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Characterization of the cytokine profile during the early phase of COVID-19

    Time frame: Measurement at Day 7 of COVID-19

    Measurement of 29 cytokines by Luminex including type I and Type III Interferon

  2. Characterization of the cytokine profile during the inflammatory phase of COVID-19

    Time frame: Measurement at Day 14 of COVID-19]

    Measurement of 29 cytokines by Luminex including type I and Type III Interferon

Sponsors and collaborators

Lead sponsor

AURA Paris

Other

Registry information

Official study title

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

Acronym: IMMUNOVIDIAL

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2022
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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