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

NCT04371510 | Completed

• 1 other identifier: 20-PP-08
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 by SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

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

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

  10 months

Study Arms (1)

Covid-19 patients with moderate symptoms

OTHER

Whole blood, culture supernatant, serum

Other: blood sample

Interventions

blood sample OTHER

a blood sample is taken on Covid-19 chronic haemodialysis patients with moderate symptoms

Covid-19 patients with moderate symptoms

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage chronic renal disease requiring haemodialysis support;
• SARS-CoV-2 positive (RT-PCR);
• 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.

You may not qualify if:

• Age \> 85 years ;
• Peritoneal dialysis;
• Onset of symptoms (fever and/or cough) for more than 8 days;
• Treatment with non-steroids anti-inflammatory agents within the laste 14 days preceding onset of symptoms;
• Pregnancy;
• Under guardianship or curatorship;
• Non-affiliated person with Social Security.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de nice

Nice, Alpes-Maritimes, 06001, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• sicard antoine, ph

  Néphrologie, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PredictCOVID-D study. Covid-19 chronic haemodialysis patients with moderate symptoms

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 1, 2020
• Study Start: May 20, 2020
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)