NCT04394195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

28 days

First QC Date

May 16, 2020

Last Update Submit

March 31, 2021

Conditions

CORONAVIRUS INFECTIONS

Outcome Measures

Primary Outcomes (1)

  • Association between concentration of circulating sFlt1 and use of vasopressor

    14 days

Study Arms (1)

patients with COVID-19 infection

patients with COVID-19 infection

Other: measurement of circulating sFlt1 concentration

Interventions

measurement of circulating sFlt1 concentrationOTHER

blood circulating sFlt1 concentration will be determined

patients with COVID-19 infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

  • Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.

    PMID: 32672790DERIVED

Biospecimen

Retention: NONE RETAINED

blood

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 19, 2020

Study Start

April 3, 2020

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations

FR(1)