Clinical trial NCT04369456: Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
Official title: Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Coronavirus Infection
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Lyon Univerity Hospital
city: Marseille
country: France
facility: APHM
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Nice
country: France
facility: University Nice Hospital
city: Paris
country: France
facility: APHP
city: Saint-Étienne
country: France
facility: Saint Etienne University Hospital
city: Strasbourg
country: France
facility: Strasbourg Univeristy Hospital
Study officials:
References: