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

A

AURA Paris

Status

Completed

Conditions

COVID-19
Cytokine Storm
Dialysis; Complications

Study type

Observational

Funder types

Other

Identifiers

NCT05307601
2020-A01426-33

Details and patient eligibility

About

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

Full 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

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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