Trial · NCT04382924
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Clinical Status (on the WHO 7-point Ordinal Scale) at Day 15 in IP Versus SOC Control Group Patients: | Day 15 | 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death |
| Secondary | Status on an Ordinal Scale Assessed Daily While Hospitalized and on Days 15 and 28 in IP Versus Control Group Patients | Days 1 through 28 | WHO status of subjects at timepoints from baseline to day 28 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death |
| Secondary | NEWS Assessed Days 3, 5, 8 ,11 Daily While Hospitalized and on Days 15 and 29 in IP Versus Control Group Patients | Days 3, 5, 8, 11, 25, 29 | National Early Warning Score assessed between baseline and Day 29 on subjects in 20, 40 mg TID NP-120 arms versus control group The National Early Warning Score (NEWS) scale is a composite of 7 physiological parameters: Respiration Rate (per minute),Oxygen Saturations (%), Any Supplemental Oxygen, Temperature (°C), Systolic BP (mmHg), Heart Rate (per minute), Level of Consciousness. The aggregate results from all 7 physiological parameters are used to obtain the NEW Score., ranging from 0 - 20. Higher values reflect a worse outcome. |
| Secondary | Rate of Mechanical Ventilation in IP Versus Control Group Patients | Up to Day 28 | Rate of mechanical ventilation in 20 and 40 mg TID NP-120 versus control group |
| Secondary | Duration of Mechanical Ventilation (if Applicable) in IP Versus Control Group Patients | Up to day 28 | Duration of mechanical ventilation in 20 and 40 mg TID subjects versus control who experience mechanical ventilation |
| Secondary | Duration of Supplemental Oxygen in IP Versus Control Group Patients | Up to Day 29 | Duration in patients only receiving supplemental oxygen in IP versus control group up to Day 29 |
| Secondary | Time to Return to Room Pressure (SpO2 > 94%) on Room Air | Up to Day 29 | Time to return to room pressure (SpO2 \> 94%) on room air in patients in 20, 40 mg TID NP-120 groups versus control group with 94% blood oxygen levels at enrolment Time-to-event endpoints with competing risk were analysed for each dosing group using the Cumulative Incidence Function-CIF (KM) graphical display. Data represents the time (in Days) it took for all participants in the group to return to room pressure air (e.g. the time when the CIF curve hit 100%). |
| Secondary | Duration in ICU (if Applicable) in IP Versus Control Group Patients | Up to Day 29 | Duration of subject in ICU in 20 and 40 TID mg groups versus control group patients |
| Secondary | Rate of Mortality in IP Versus Control Group Patients | Up to Day 29 | Rate of Overall Mortality in 20, 40 mg TID groups versus control group |
| Secondary | Duration of Hospitalization in IP Versus Control Group Patients | Day 15, 28 | |
| Secondary | Time to Discharge in IP Versus Control Group Patients | Day 15, 28 | |
| Secondary | Effect on the Rate of Change of Partial Pressure of Oxygen (PaO2) and PaO2/FiO2 Ratio Taken at Baseline and Measured Once Daily up to 2 Weeks of Treatment in IP Versus Control Group Patients | Up to day 15, day 28 |
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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