Trial · NCT04817332
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 | Comparison of Participant Clinical Status Between Treatment Arms | Up to 29 days | To determine the participant clinical status on a 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitation on activities; 3. Hospitalised, not requiring supplemental oxygen; 4. Hospitalised, requiring supplemental oxygen; 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death. |
| Secondary | Improvement of One Category From Admission Using 7-point Ordinal Scale. | Day 29 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations on activities 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices 6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death |
| Secondary | Participant Clinical Status on 7-point Ordinal Scale | Day 15 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations on activities 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices 6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death |
| Secondary | Mean Change in the 7-point Ordinal Scale | Baseline to days 3, 5, 8, 11 and 29 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: 7-point ordinal scale, minimum value 1, maximum value 7. Higher values indicate a worse outcome: 1. Not hospitalised, no limitations on activities 2. Not hospitalised, limitations on activities 3. Hospitalised, not requiring supplemental oxygen 4. Hospitalised, requiring supplemental oxygen 5. Hospitalised, on non-invasive ventilation or high flow oxygen devices 6. Hospitalised, on invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO) 7. Death |
| 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 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score (NEWS). NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes. |
| Secondary | Change From Baseline of National Early Warning Score (NEWS). | Baseline to day 15 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: National Early Warning Score. NEWS is a system that scores 6 physiological parameters (respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new-onset confusion, temperature) to give an aggerate score. Minimum score is 1, maximum score is 20.. Higher scores indicate worsening clinical outcomes. |
| Secondary | Number of Oxygen Therapy Free Days | 1-29 days | Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation |
| Secondary | Incidence and Duration of New Oxygen Therapy Use During the Trial | 0-29 days | Evaluation of the clinical efficacy of Brensocatib relative to standard care: oxygenation |
| Secondary | Number of Mechanical Ventilator Free Days | 1-29 days | Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation |
| Secondary | Incidence and Duration of New Mechanical Ventilation Use During the Trial. | 1-29 days | Evaluation of the clinical efficacy of Brensocatib relative to standard care: Mechanical ventilation |
| Secondary | Duration of Hospitalisation (Days). | Duration between date of admission and discharge assessed up to 29 days. | Evaluation of the clinical efficacy of Brensocatib relative to standard care: hospitalisation |
| Secondary | 28-day Mortality | Day 1 to 29 | Evaluation of the clinical efficacy of Brensocatib relative to standard care: mortality. Survival analysis was used to compare 28-day mortality between the treatment arms. Participants who did not die were censored on the last study day. Those who withdrew or were loss to follow-up and their day 29 status was unknown were censored at the date of loss to follow-up/withdrawal. Other participants were censored 28 days from randomisation in study time. |
| Secondary | Cumulative Incidence of Serious Adverse Events (SAEs) | 1-29 days | Evaluation of the safety of the intervention through 29 days of follow-up as compared to the control arm |
| Secondary | Discontinuation or Temporary Suspension of Treatment | 1-29 days | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in White Cell Count (x10^9/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in Haemoglobin (g/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in Platelets (x10^9/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in Creatinine (Umol/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in Total Bilirubin (Umol/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
| Secondary | Changes in Alanine Aminotransferase (U/L) Over Time (Hospitalised Participants Only) | Day 29 | Evaluation of the safety of the intervention through 28 days of follow-up as compared to the control arm |
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.
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GET https://conductscience.org/api/trials/v1/NCT04817332/registered