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

• Sponsor: CHU de Reims (Other)
• Overall Status: Completed
• CT.gov ID: NCT04394195
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 14.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CORONAVIRUS INFECTIONS	Other: measurement of circulating sFlt1 concentration

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 Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
• Actual Study Start Date: Apr 3, 2020
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Association between concentration of circulating sFlt1 and use of vasopressor [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Reims	Reims		France	51092

Sponsors and Collaborators

• CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CHU de Reims
• ClinicalTrials.gov Identifier: NCT04394195
• Other Study ID Numbers: PO20043*
• First Posted: May 19, 2020
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronavirus Infections

Study Results

No Results Posted as of Apr 1, 2021