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

NCT04369456 | Completed

• 1 other identifier: 20-PP-09
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 7

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 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 investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff 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 kidney transplant patients with moderate symptoms followed in 9 centers.

Conditions

Kidney Transplant; Complications; Coronavirus 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 kidney transplant patients.

  10 months

Study Arms (1)

Covid-19 kidney transplant patients with moderate symptoms

OTHER

Other: blood sample

Interventions

blood sample OTHER

a blood sample is taken on Covid-19 kidney transplant patients with moderate symptoms

Covid-19 kidney transplant 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:

• Kidney or kidney-pancreas or kidney-heart transplant patients;
• 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 ;
• Kidney-liver transplant patients;
• Onset of symptoms (fever and/or cough) for more than 8 days;
• Treatment with non-steroids anti-inflammatory agents within the last 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 (7)

Lyon Univerity Hospital

Lyon, 69000, France

Location

APHM

Marseille, 13000, France

Location

Montpellier University Hospital

Montpellier, 34000, France

Location

University Nice Hospital

Nice, 06000, France

Location

APHP

Paris, 75000, France

Location

Saint Etienne University Hospital

Saint-Etienne, 42000, France

Location

Strasbourg Univeristy Hospital

Strasbourg, 67000, France

Location

Related Publications (1)

• Cremoni M, Cuozzo S, Martinuzzi E, Barbosa S, Ben Hassen N, Massa F, Demonchy E, Durand M, Thaunat O, Esnault V, Le Quintrec M, Caillard S, Glaichenhaus N, Sicard A. Low T Cell Responsiveness in the Early Phase of COVID-19 Associates with Progression to Severe Pneumonia in Kidney Transplant Recipients. Viruses. 2022 Mar 5;14(3):542. doi: 10.3390/v14030542.

  PMID: 35336949 RESULT

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: September 8, 2020
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)