Covid19 Clinical Trial
— PAMOCOSOfficial title:
ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
| NCT number | NCT04522310 |
| Other study ID # | 2020-05 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 7, 2020 |
| Est. completion date | May 29, 2021 |
| Verified date | August 2021 |
| Source | Centre Hospitalier de Lens |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 183 |
| Est. completion date | May 29, 2021 |
| Est. primary completion date | February 28, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospital of Arras | Arras | |
| France | Hospital of Boulogne/mer | Boulogne-sur-Mer | |
| France | Hospital of DOUAI | Douai | |
| France | Hospital of Dunkerque | Dunkerque | |
| France | Hospital Dr Schaffner | Lens | |
| France | Hospital of Roubaix | Roubaix | |
| France | Hospital of Tourcoing | Tourcoing | |
| France | Hospitalier of Valenciennes | Valenciennes |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier de Lens |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | mortality at day 28 and day 90. | mortality at day 28 and day 90. | admission until day 90 | |
| Secondary | Association between MR-ProADM and mortality at day 28. | Association between MR-ProADM and mortality at day 28. | admission until day 28 | |
| Secondary | 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 |
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