Trial · NCT04382755
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Oxygenation | at predose, day 6 and day 15 (or at discharge, whichever comes first) | defined by Pa02/FiO2 ratio while breathing room air, P(Aa)O2 gradient and a/A pO2 ratio |
| Secondary | Mean Change in 6-point Ordinal Scale Change for Clinical Improvement | between day 1 and respectively day 6, day 15 (or discharge, whichever comes first) and day 28 (by phone call). | 6-point ordinal scale defined as 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO; 3. Hospitalized, on non-invasive ventilation 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen 6. Not hospitalized |
| Secondary | Number of Days With Hypoxia | during hospital admission (up to 28 days) | defined as SpO2 \< 93% breathing room air or the dependence on supplemental oxygen |
| Secondary | Number of Days of Supplemental Oxygen Use | during hospital admission (up to 28 days) | |
| Secondary | Time to Absence of Fever (Defined as 37.1°C or More) for More Than 48h Without Antipyretic | during hospital admission (up to 28 days) | |
| Secondary | Number of Days With Fever | during hospital admission (up to 28 days) | defined as 37.1°C or more |
| Secondary | Mean Change in CRP Levels Between Day 1 and Day 6 | day 1, day 6 | |
| Secondary | Mean Change in CRP Levels Between Day 1 and Day 15 (or Discharge Whichever Comes First) | day 1, day 15 | |
| Secondary | Mean Change in Ferritin Levels Between Day 1 and Day 6 | day 1, day 6 | |
| Secondary | Mean Change in Ferritin Levels Between Day 1 and Day 15 (or Discharge, Whichever Comes First) | day 1, day 15 | |
| Secondary | Number of Participants With Adverse Events | during hospital admission (up to 28 days) | Any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Secondary | Number of Participants With Serious Adverse Events | at 10-20 weeks follow-up | A serious adverse event is any untoward medical occurrence that: * results in death * is life-threatening * requires inpatient hospitalisation or prolongation of existing hospitalisation * results in persistent or significant disability/incapacity * consists of a congenital anomaly or birth defect Other 'important medical events' may also be considered serious if they jeopardise the subject or require an intervention to prevent one of the above consequences. NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe. |
| Secondary | Number of Participants With SUSAR's (Suspected Unexpected Serious Adverse Reaction) | during hospital admission (up to 28 days) | A serious adverse reaction, the nature and severity of which is not consistent with the information about the medicinal product in question set out: * in the case of a product with a marketing authorisation, in the summary of product characteristics (SmPC) for that product * in the case of any other investigational medicinal product, in the investigator's brochure (IB) relating to the study in question |
| Secondary | Number of Participants With SAR's (Serious Adverse Reaction) | during hospital admission (up to 28 days) | An adverse event that is both serious and, in the opinion of the reporting Investigator, believed with reasonable probability to be due to one of the study treatments, based on the information provided. |
| Secondary | Duration of Hospital Stay | at 12-22 weeks follow-up | |
| Secondary | Duration of Hospital Stay in Survivors | at 12-22 weeks follow-up | |
| Secondary | Number of Participants With Improvement, No Change, Death or Deterioration in SOFA Score Between Day 1 and Day 6 (or on Discharge, Whichever is First) | day 1, day 6 or on discharge, whichever is first | The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). Score ranges from 0 (best) to 24 (worst) points. |
| Secondary | Number of Participants With Improvement, No Change, Death or Deterioration in SOFA Score Between Day 1 and Day 15 (or on Discharge, Whichever is First) | day 1, day 15 or on discharge, whichever is first | The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems). Score ranges from 0 (best) to 24 (worst) points. |
| Secondary | Number of Participants With Nosocomial Bacterial or Invasive Fungal Infection for 28 Days (Phone Call) After Enrollment in Trial | day 28 | |
| Secondary | Median Time to at Least a 2-point Improvement on the 6-point Ordinal Scale or Discharge During the 28-day Assessment Period (Range) - Days | Day 28 | The 6-point ordinal scale for clinical improvement is defined as 1 = Death; 2 = Hospitalized, on invasive mechanical ventilation or ECMO; 3 = Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 = Hospitalized, requiring supplemental oxygen; 5 = Hospitalized, not requiring supplemental oxygen; 6 = Not hospitalized. A higher score represent a better outcome |
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
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GET https://conductscience.org/api/trials/v1/NCT04382755/registered