Trial · NCT04339712
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of baseline total sequential organ failure assessment (SOFA) score | Visit study day 8 | At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8 |
| Primary | Improvement of lung involvement measurements | Visit study day 8 | Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8 |
| Primary | Increase of pO2/FiO2 ratio | Visit Study Day 8 | At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8 |
| Secondary | Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators | Screening, Day 8 | Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome) |
| Secondary | Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators | Screening, Day 8 | Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database |
| Secondary | Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators | Screening, Day 8 | Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database |
| Secondary | Change of sequential organ failure assessment (SOFA) score | Day 28 | Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome) |
| Secondary | Rate of Mortality | Day 28 | Mortality on day 28 |
| Secondary | Rate of Mortality | Day 90 | Mortality on day 90 |
| Secondary | Cytokine stimulation | Screening, Day 4 | Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4 |
| Secondary | Gene expression | Screening, Day 4 | Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4 |
| Secondary | Serum/plasma proteins | Screening, Day 4 | Change of serum/plasma proteins between days 0 and 4 |
| Secondary | Classification of the immune function | Screening | Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04339712/registered