Immune Response Following COVID-19 in Hemodialysis Patients (IMMUNOVIDIAL)

March 31, 2022 updated by: AURA Paris

Evaluation of the Cytokine 's Profile Following SarsCov 2 Infection (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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • AURA Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult HD patients from 2 main dialysis units of the AURA: AURA Paris Plaisance and Saint-Ouen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measurement at Day 7 of COVID-19
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
Measurement at Day 14 of COVID-19]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AURA Paris

Investigators

  • Principal Investigator: Maxime Touzot, MD, PhD, AURA Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A01426-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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