NCT04544891

Brief Summary

Severe Acute Respiratory Syndrome-Corona Virus-2 infection results in a mild infection in most of the patients. However, 15-20% require hospitalization, and among them, 15-20% will develop acute respiratory failure, leading to their admission in Intensive Care Unit. There are no accepted predictive criteria for aggravation. Severe forms of Coronavirus induced disease-19 (COVID-19) are the consequence of endotheliopathy, and hyperinflammatory and pro-coagulant state. The Triggering Receptor Expressed on Myeloid cells-1 (TREM-1) is an immunoreceptor that acts as an amplifier of the inflammatory response. TREM-1 is expressed on myeloid and endothelial cells. Its activation leads to endothelial activation and damage, hyperinflammatory, and pro-coagulant state. TREM-1 activation is associated with poor outcome during septic shock and myocardial infarction. We here aim at investigating the relationship between TREM-1 pathway activation and clinical degradation and outcome of COVID-19 hospitalized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

September 9, 2020

Last Update Submit

March 8, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • prognostic value of the TREM-1 pathway activation on clinical worsening

    day 28

Interventions

blood samplingOTHER

Blood will be collected every 3 days until Day 28, discharge, or death

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1000 consecutive COVID-19 patients hospitalized for less than 3 days; among them at least 200 patients hospitalized in ICU (primary admission or secondary transfer from the ward)

You may not qualify if:

  • No consent Pregnancy protected populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU Limoges

Limoges, 87042, France

Location

Central hospital

Nancy, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 10, 2020

Study Start

October 1, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

FR(2)