Status:

COMPLETED

Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients

Lead Sponsor:

Centre Hospitalier Universitaire de Nice

Conditions:

Kidney Transplant; Complications

Coronavirus Infection

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 diseas...

Eligibility Criteria

Inclusion

  • Kidney or kidney-pancreas or kidney-heart transplant patients;
  • SARS-CoV-2 positive (RT-PCR);
  • COVID-19 symptoms at least once over a 8-day period preceding inclusion;
  • Hospitalized or outpatients in one of the study centers: CHU de Nice, CHU de Strasbourg, Hôpital Necker (APHP), Hôpital Kremlin Bicêtre (APHP), Hôpital Pitié-Salpétriêre (APHP), Hospices Civils de Lyon, CHU de Saint-Etienne, CHU de Montpellier, Hôpital La Conception (APHM);
  • Age \> 18 years;
  • Free and informed consent.

Exclusion

  • Age \> 85 years ;
  • Kidney-liver transplant patients;
  • Onset of symptoms (fever and/or cough) for more than 8 days;
  • Acute respiraytory distress despite oxygen therapy, 02 ≥ 4L/min, arterial pressure \< 85/55 mmHg or hemodynamic instability at time of inclusion, encephalopathy with Glasgow coma scale \< 14;
  • Treatment with non-steroids anti-inflammatory agents within the last 14 days preceding onset of symptoms;
  • Active bacterial or fungal infection documented at inclusion;
  • Pregnancy;
  • Under guardianship or curatorship;
  • Non-affiliated person with Social Security

Key Trial Info

Start Date :

September 8 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 21 2021

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT04369456

Start Date

September 8 2020

End Date

April 21 2021

Last Update

February 6 2024

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Lyon Univerity Hospital

Lyon, France, 69000

2

APHM

Marseille, France, 13000

3

Montpellier University Hospital

Montpellier, France, 34000

4

University Nice Hospital

Nice, France, 06000