Trial · NCT04356833
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 | Efficacy - PaO2/FiO2 Ratio | Day 14 and last value available on treatment (which could occur up to 14 days, death or discharge may have occurred within 14 days) | PaO2/FiO2 measured at multiple timepoints: baseline, during treatment, end of treatment, 3 days post end of treatment and 5 days post end of treatment. For Cohort 1, all available values were extracted per day and summarised every 4 hours (± 2h). For Cohort 2, up to six values were extracted per days including the worst ratio over the preceding day; Cohort 2 included only the lowest value for the day. PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure to fractional inspired oxygen. It is a widely used clinical indicator of hypoxaemia and is used to classify severity of acute respiratory distress syndrome. Limited data was observed due to patient discharge or death: Day 14 is presented below, and the last value available on treatment regardless of the duration of treatment (death or discharge may have occurred within 14 days) was summarised post-hoc. Summarized values were rounded to the nearest integer. |
| Primary | Safety- Participants With Major Bleeding Events Directly Attributable to Study Drug | 28 days | Number of patients with major bleeding events assessed as related to the study drug summarised in each group. |
| Primary | Safety- Participants With Serious Adverse Events Causally Related to Treatment | 28 days | Number of Participants with serious adverse events causally related to treatment. Adverse events (other than bleeding events) were not recorded in the study. |
| Primary | Safety- Participants With Decrease in Fibrinogen Levels to < 1gm/L | 28 days | Number of participants with a decrease in fibrinogen levels to \< 1gm/L during the treatment period and 48 hours after the last dose. |
| Secondary | Lung Compliance | Last value available on treatment (which could occur up to 14 days, death or discharge may have occurred within 14 days) | Changes in lung compliance (defined as tidal volume / (peak inspiratory pressure - PEEP) from baseline (same day as start of treatment but prior to start of treatment) was a secondary outcome as defined in the protocol. Limited data was observed due to patient discharge or death, therefore the last value available on treatment regardless of the duration of treatment (death or discharge may have occurred within 14 days) was summarised post-hoc and presented below. For cohort 2, the daily measurement coinciding with the worst PF ratio (as close as possible in date and time) was used for the summaries. |
| Secondary | Clinical Status as Determined by a 7-point WHO Ordinal Scale | Day 28 | Clinical status as assessed by a 7-point WHO ordinal scale at baseline and daily up to 5 days post end of treatment and at day 28, discharge or death (whichever comes first). 1. Limitation of activities 2. Hospitalized, no oxygen therapy 3. Oxygen by mask or nasal prongs 4. Non-invasive ventilation or high-flow oxygen 5. Intubation and mechanical ventilation 6. Ventilation+ additional organ support (vasopressor, RRT, ECMO) 7. Death |
| Secondary | Sequential Organ Failure Assessment (SOFA) Score | 28 days (day 14 presented) | The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction. It requires the following (worst value within past 24 hours): FiO2, PaO2, Mechanical ventilation, Platelets, Bilirubin, Glasgow coma scale, Mean arterial pressure, Vasopressors, Creatinine, Urine output, and can be calculated by entering the results above into an online tool: https://clincalc.com/IcuMortality/SOFA.aspx. The SOFA Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. A higher value for each organ system is associated with higher mortality, and here total score was used. The total possible score ranges from 0 to 24. |
| Secondary | Number of Oxygenation Free Days | up to 28 days or death or discharge, whichever occurred first | Number of oxygen free days, up to 28 days or death or discharge, whichever occured first. |
| Secondary | Number of Ventilator Free Days | up to 28 days or death or discharge, whichever occured first | Number of ventilator free days, up to 28 days or death or discharge, whichever occured first |
| Secondary | Intensive Care Stay | 28 days | Intensive care stay, up to 28 days or death or discharge, whichever occurs first, was a secondary outcome as defined in the protocol. However, due to protocol amendments, difficulties in collecting this data, differences in study design between cohort 1 and cohort 2 and limited comparability of this outcome measure between groups, results are presented but have limited interpretation and should not be used or compared. For cohort 1, the number of days in ICU were limited to the 1st admission. |
| Secondary | Number of Days of New Mechanical Ventilation Use During in the First 28 Days | 28 days | incidence and number of days of new mechanical ventilation use during in the first 28 days was a secondary outcome measure as defined in the protocol. |
| Secondary | Number of Days of Non-invasive Ventilation Use | Day 28 | Number of days of new oxygen use, non-invasive ventilation or high flow oxygen devices |
| Secondary | In-hospital Mortality | 28 days | In-hospital mortality. |
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.
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