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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-04-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplant; Complications Coronavirus Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Covid-19 kidney transplant patients with moderate symptoms

Group Type OTHER

blood sample

Intervention Type OTHER

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

Interventions

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blood sample

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No