sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19? (COVIDsFlt1)

March 31, 2021 updated by: CHU de Reims
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)

The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Reims, France, 51092
        • Chu Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients with COVID-19 hospitalized in University Hospital of Reims

Description

Inclusion Criteria:

  • Patient with documented COVID-19 (positive PCR)
  • Hospitalized in University Hospital of Reims
  • Patient or family who have previously consented

Exclusion Criteria:

  • Patient <18 yo
  • Patient not insured under the French social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with COVID-19 infection
Other: measurement of circulating sFlt1 concentration
blood circulating sFlt1 concentration will be determined

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between concentration of circulating sFlt1 and use of vasopressor
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

May 16, 2020

First Submitted That Met QC Criteria

May 16, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO20043*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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