ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis (PAMOCOS)

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: MR-Pro-ADM

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• France
  • Arras, France, 62000
    • Hospital of Arras
  • Boulogne-sur-Mer, France, 62200
    • Hospital of Boulogne/mer
  • Douai, France, 59507
    • Hospital of DOUAI
  • Dunkerque, France, 59240
    • Hospital of Dunkerque
  • Lens, France, 62307
    • Hospital Dr Schaffner
  • Roubaix, France, 59100
    • Hospital of Roubaix
  • Tourcoing, France, 59200
    • Hospital of Tourcoing
  • Valenciennes, France, 59300
    • Hospitalier of Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between MR-ProADM and mortality at day 28.	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.	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Lens

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): May 29, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Shock; COVID-19; Multiple Organ Failure
• Other Study ID Numbers: 2020-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No