NCT04522310

Brief Summary

COVID-19 is a worldwide pandemic. Around 5% of infected patients are admitted in ICU, mainly for respiratory failure. Outcome of these patients is linked to other organ failures. Optimal therapies are not defined so far. The sponsor want to assess the role of MR-ProADM as prognostic biomarker, and the impact of treatments (including supportive treatments) on MOF occurrence and outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

8 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

Study Start

First participant enrolled

July 7, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

July 17, 2020

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.

    Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.

    comparison to day 1 and day 3

  • mortality at day 28 and day 90.

    mortality at day 28 and day 90.

    admission until day 90

Secondary Outcomes (2)

  • Association between MR-ProADM and mortality at day 28.

    admission until day 28

  • Association or correlation between patient factor or treatment, and the onset or aggravation of visceral failures (day 3 and day 10), evolution until day 28.

    admission until day 28

Interventions

Dosage of MR-pro-ADM

Eligibility Criteria

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

Any adult patient admitted in the ICU with COVID-19 pneumonia

You may qualify if:

  • Any adult patient admitted in the ICU with COVID-19 pneumonia

You may not qualify if:

  • Pregnancy
  • Legal reasons (patients under guardianship, curatorship)
  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital of Arras

Arras, 62000, France

Location

Hospital of Boulogne/mer

Boulogne-sur-Mer, 62200, France

Location

Hospital of DOUAI

Douai, 59507, France

Location

Hospital of Dunkerque

Dunkirk, 59240, France

Location

Hospital Dr Schaffner

Lens, 62307, France

Location

Hospital of Roubaix

Roubaix, 59100, France

Location

Hospital of Tourcoing

Tourcoing, 59200, France

Location

Hospitalier of Valenciennes

Valenciennes, 59300, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

mid-regional pro-adrenomedullin, human

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

July 17, 2020

First Posted

August 21, 2020

Study Start

July 7, 2020

Primary Completion

February 28, 2021

Study Completion

May 29, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations