Trial · NCT04817332
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Participant Clinical Status Between Treatment Arms | Up to 29 days | Intention to treat | participants | NUMBER |
| SECONDARY | Improvement of One Category From Admission Using 7-point Ordinal Scale. | Day 29 | ITT. Days to improvement was derived as~1. days from randomization to date of first follow-up day where there was an improvement in CSTAT~2. those who died before improvement were censored at date of death.~3. those who withdrew or were loss to follow-up before improvement, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal~4. other participants were censored at day 29 from randomisation in study time if there were no improvement. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participant Clinical Status on 7-point Ordinal Scale | Day 15 | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in the 7-point Ordinal Scale | Baseline to days 3, 5, 8, 11 and 29 | ITT | Units on WHO scale | MEAN |
| SECONDARY | Number of Participants Discharged or to a National Early Warning Score (NEWS) of Equal or Less Than 2 and Maintained for 24 Hours, Whichever Occurs First. | Up to 29 days | ITT. Those who died before being discharged or having a NEWS of ≤ 2 were censored at date of death. For those who withdrew or were loss to follow-up before being discharged or having a NEWS of ≤ 2, if their day 29 status was unknown, they were censored at the date of loss to follow-up/withdrawal. Other participants were censored at day 29 or 28 days from randomisation in study time if they were still in hospital and never had a NEWS of ≤ 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline of National Early Warning Score (NEWS). | Baseline to day 15 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Oxygen Therapy Free Days | 1-29 days | ITT. | days | MEDIAN |
| SECONDARY | Incidence and Duration of New Oxygen Therapy Use During the Trial | 0-29 days | For the duration of new oxygen use analysis, only participants who were hospitalised but not requiring supplemental oxygen (CSTAT = 3) at baseline were included | days | MEDIAN |
| SECONDARY | Number of Mechanical Ventilator Free Days | 1-29 days | ITT | days | MEDIAN |
| SECONDARY | Incidence and Duration of New Mechanical Ventilation Use During the Trial. | 1-29 days | days | MEDIAN | |
| SECONDARY | Duration of Hospitalisation (Days). | Duration between date of admission and discharge assessed up to 29 days. | days | MEAN | |
| SECONDARY | 28-day Mortality | Day 1 to 29 | ITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Incidence of Serious Adverse Events (SAEs) | 1-29 days | There were two post-randomisation exclusions due to ineligibility in the brensocatib group (one patient was admitted to hospital as an inpatient more than 96 h before randomisation and another was receiving a prohibited medication). These 2 excluded patients were included with the ITT population in the safety analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Discontinuation or Temporary Suspension of Treatment | 1-29 days | Safety | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes in White Cell Count (x10^9/L) Over Time (Hospitalised Participants Only) | Day 29 | Hospitalised participants only | 10^9cells/L | MEAN |
| SECONDARY | Changes in Haemoglobin (g/L) Over Time (Hospitalised Participants Only) | Day 29 | Hospitalised participants only | g/l | MEAN |
| SECONDARY | Changes in Platelets (x10^9/L) Over Time (Hospitalised Participants Only) | Day 29 | Safety | 10^9cells/L | MEAN |
| SECONDARY | Changes in Creatinine (Umol/L) Over Time (Hospitalised Participants Only) | Day 29 | Hospitalised patients only | umol/L | MEAN |
| SECONDARY | Changes in Total Bilirubin (Umol/L) Over Time (Hospitalised Participants Only) | Day 29 | Safety | umol/L | MEAN |
| SECONDARY | Changes in Alanine Aminotransferase (U/L) Over Time (Hospitalised Participants Only) | Day 29 | safety | U/L | MEAN |
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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