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

Coronavirus Infection Clinical Trial

— PredictCovidT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369456
• Other study ID #: 20-PP-09
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Disease Progression
• Kidney Transplant; Complications

Intervention

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

Locations

Country	Name	City	State
France	Lyon Univerity Hospital	Lyon
France	APHM	Marseille
France	Montpellier University Hospital	Montpellier
France	University Nice Hospital	Nice
France	APHP	Paris
France	Saint Etienne University Hospital	Saint-Étienne
France	Strasbourg Univeristy Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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