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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Kidney Transplant; Complications
• Intervention / Treatment: Other: blood sample

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Lyon Univerity Hospital
  • Marseille, France, 13000
    • APHM
  • Montpellier, France, 34000
    • Montpellier University Hospital
  • Nice, France, 06000
    • University Nice Hospital
  • Paris, France, 75000
    • APHP
  • Saint-Etienne, France, 42000
    • Saint Etienne University Hospital
  • Strasbourg, France, 67000
    • Strasbourg Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Covid-19 kidney transplant patients with moderate symptoms	Other: blood sample; a blood sample is taken on Covid-19 kidney transplant patients with moderate symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): April 21, 2021
• Study Completion (Actual): April 21, 2021

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Coronavirus Infections; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 20-PP-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No