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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04522310
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Lens

Study Description
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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.

Condition or disease Intervention/treatment
Covid19 Other: MR-Pro-ADM

Study Design
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Study Type : Observational
Actual Enrollment : 183 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
Actual Study Start Date : July 7, 2020
Actual Primary Completion Date : February 28, 2021
Actual Study Completion Date : May 29, 2021

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Groups and Cohorts
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Intervention Details:
  • Other: MR-Pro-ADM
    Dosage of MR-pro-ADM

Outcome Measures
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Primary Outcome Measures :
  1. Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation. [ Time Frame: comparison to day 1 and day 3 ]
    Association or correlation between MR-ProADM at day 1 and day 3 and the onset of visceral failures extra respiratory in reanimation.

  2. mortality at day 28 and day 90. [ Time Frame: admission until day 90 ]
    mortality at day 28 and day 90.


Secondary Outcome Measures :
  1. Association between MR-ProADM and mortality at day 28. [ Time Frame: admission until day 28 ]
    Association between MR-ProADM and mortality at day 28.

  2. 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. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult patient admitted in the ICU with COVID-19 pneumonia
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522310


Locations
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France
Hospital of Arras
Arras, France, 62000
Hospital of Boulogne/mer
Boulogne-sur-Mer, France, 62200
Hospital of DOUAI
Douai, France, 59507
Hospital of Dunkerque
Dunkerque, France, 59240
Hospital Dr Schaffner
Lens, France, 62307
Hospital of Roubaix
Roubaix, France, 59100
Hospital of Tourcoing
Tourcoing, France, 59200
Hospitalier of Valenciennes
Valenciennes, France, 59300
Sponsors and Collaborators
Centre Hospitalier de Lens
More Information
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Responsible Party: Centre Hospitalier de Lens
ClinicalTrials.gov Identifier: NCT04522310    
Other Study ID Numbers: 2020-05
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Multiple Organ Failure
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Shock