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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT04369456
Collaborator
(none)
115
Enrollment
7
Locations
1
Arm
6
Anticipated Duration (Months)
16.4
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: blood sample
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
115 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients
Actual Study Start Date :
Apr 22, 2020
Anticipated Primary Completion Date :
Oct 22, 2020
Anticipated Study Completion Date :
Oct 22, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Predictive value of IL-6 contents of whole blood samples after ex vivo stimulation [10 months]

    quantity of IL-6 in of whole blood samples after ex vivo co-stimulation with LPS and ATP in Covid-19 kidney transplant patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lyon Univerity Hospital Lyon France 69000
2 APHM Marseille France 13000
3 Montpellier University Hospital Montpellier France 34000
4 University Nice Hospital Nice France 06000
5 APHP Paris France 75000
6 Saint Etienne University Hospital Saint-Étienne France 42000
7 Strasbourg Univeristy Hospital Strasbourg France 67000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04369456
Other Study ID Numbers:
  • 20-PP-09
First Posted:
Apr 30, 2020
Last Update Posted:
May 1, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronavirus Infections
Disease Progression

Study Results

No Results Posted as of May 1, 2020