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

Completed

• Conditions: CORONAVIRUS INFECTIONS
• Interventions: Other: measurement of circulating sFlt1 concentration

• Registration Number: NCT04394195
• Lead Sponsor: CHU de Reims

Brief Summary

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.

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 Timeline

• Study Start: 2020-04-03
• Primary Completion: 2020-05-01
• Study First Submitted: 2020-05-16
• Study First Submitted QC: 2020-05-16
• Study First Posted: 2020-05-19
• Study Completion: 2020-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with COVID-19 infection	measurement of circulating sFlt1 concentration	patients with COVID-19 infection

Primary Outcome Measures

Name	Time	Method
Association between concentration of circulating sFlt1 and use of vasopressor	14 days

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France