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

• Sponsor: Centre Hospitalier de Lens (Other)
• Overall Status: Completed
• CT.gov ID: NCT04522310
• Collaborator: (none)
• Enrollment: 183
• Locations: 8
• Actual Duration (Months): 10.7
• Patients Per Site: 22.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Phase
Covid19	Other: MR-Pro-ADM

Study Design

• 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: Jul 7, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: May 29, 2021

Outcome Measures

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. [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. [admission until day 90]

   mortality at day 28 and day 90.

Secondary Outcome Measures

1. Association between MR-ProADM and mortality at day 28. [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. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital of Arras	Arras		France	62000
2	Hospital of Boulogne/mer	Boulogne-sur-Mer		France	62200
3	Hospital of DOUAI	Douai		France	59507
4	Hospital of Dunkerque	Dunkerque		France	59240
5	Hospital Dr Schaffner	Lens		France	62307
6	Hospital of Roubaix	Roubaix		France	59100
7	Hospital of Tourcoing	Tourcoing		France	59200
8	Hospitalier of Valenciennes	Valenciennes		France	59300

Sponsors and Collaborators

• Centre Hospitalier de Lens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier de Lens
• ClinicalTrials.gov Identifier: NCT04522310
• Other Study ID Numbers: 2020-05
• First Posted: Aug 21, 2020
• Last Update Posted: Aug 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Multiple Organ Failure

Study Results

No Results Posted as of Aug 5, 2021