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Clinical Trials/NCT04371510
NCT04371510
Completed
Not Applicable

Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Chronic Haemodialysis Patients

Centre Hospitalier Universitaire de Nice1 site in 1 country18 target enrollmentMay 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 by SARS-CoV-2 Infection
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
18
Locations
1
Primary Endpoint
Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation
Status
Completed
Last Updated
2 years ago

Overview

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 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal.

Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis the investigators formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome.

To test this hypothesis, the investigators propose to follow recently infected chronic haemodialysis patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The investigators plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 chronic haemodialysis patients with moderate symptoms followed in 9 centers.

Registry
clinicaltrials.gov
Start Date
May 20, 2020
End Date
August 27, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with end-stage chronic renal disease requiring haemodialysis support;
  • 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 Criteria

  • Age \> 85 years ;
  • Peritoneal dialysis;
  • 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 laste 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.

Outcomes

Primary Outcomes

Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation

Time Frame: 10 months

Quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 patients.

Study Sites (1)

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