Covid19PAMOCOSNCT04522310
ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
An observational study of Covid19, run by Centre Hospitalier de Lens at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- MR-Pro-ADM
- How many people
- 183 participants
- Where
- 8 sitesFrance
- Study dates
- 7 Jul 2020to 29 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult patient admitted in the ICU with COVID-19 pneumonia
Who may be able to join
- Any adult patient admitted in the ICU with COVID-19 pneumonia
Who cannot join
- Pregnancy
- Legal reasons (patients under guardianship, curatorship)
- Patient's refusal
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hospital of Arras
Arras, 62000
Hospital of Boulogne/mer
Boulogne-sur-Mer, 62200
Hospital of DOUAI
Douai, 59507
Hospital of Dunkerque
Dunkirk, 59240
Hospital Dr Schaffner
Lens, 62307
Hospital of Roubaix
Roubaix, 59100
Hospital of Tourcoing
Tourcoing, 59200
Hospitalier of Valenciennes
Valenciennes, 59300
About this study
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.
- Conditions
- Covid19
- Being tested
- MR-Pro-ADM
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Pro-ADMOther
Dosage of MR-pro-ADM
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: comparison to day 1 and day 3
mortality at day 28 and day 90.
mortality at day 28 and day 90.
Measured: admission until day 90
Secondary outcomes (2)
Association between MR-ProADM and mortality at day 28.
Association between MR-ProADM and mortality at day 28.
Measured: 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.
Measured: admission until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start7 Jul 2020
- Primary completion28 Feb 2021
- Study completion29 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Lens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522310
- Sponsor's protocol ID
- 2020-05
- Acronym
- PAMOCOS
- Status last verified
- Aug 2021
- First submitted
- 17 Jul 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProAdrenomedullin Assessment of Multi-Organ Failure in COvid-19 Sepsis
- ClinicalTrials.gov ID
- NCT04522310
- Acronym / sponsor ID
- PAMOCOS / 2020-05
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Centre Hospitalier de LensUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult patient admitted in the ICU with COVID-19 pneumonia
Key inclusion criteria (1 listed)
- Any adult patient admitted in the ICU with COVID-19 pneumonia
Key exclusion criteria (3 listed)
- Pregnancy
- Legal reasons (patients under guardianship, curatorship)
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-Pro-ADMDosage of MR-pro-ADM | Other | – |
Primary outcome
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.
mortality at day 28 and day 90.
Time frame: admission until day 90
mortality at day 28 and day 90.
2 secondary outcomes
Association between MR-ProADM and mortality at 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.
Time frame: admission until day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Centre Hospitalier de Lens at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.