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NCT04394195 Clinical Trial

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

CORONAVIRUS INFECTIONS Clinical Trial

— COVIDsFlt1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04394195
Other study ID # PO20043*
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 3, 2020
Est. completion date September 1, 2020

Study information
Verified date March 2021
Source CHU de Reims
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date September 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• measurement of circulating sFlt1 concentration
blood circulating sFlt1 concentration will be determined

Locations
Country Name City State
France Chu Reims Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association between concentration of circulating sFlt1 and use of vasopressor 14 days
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