Trial · NCT04771000
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects alive and not having developed respiratory failure from randomization to Day 14 | 30 days | The number of patients that are alive and have not developed respiratory failure by day 30 after entering the study will be compared between the experimental and placebo arms |
| Secondary | Proportion of subjects alive and free of respiratory failure at Day 14 and Day 30 | 14 days and 30 days | The number of patients that are alive and have not developed respiratory failure on day 14 will will be compared between the experimental and placebo arms |
| Secondary | Proportion of subjects alive and not requiring oxygen supplementation or higher respiratory support at Day 14. | 14 days | The number of patients not requiring supplemental oxygen, or any other type of respiratory support at day 14 will be compared between the experimental and placebo arms |
| Secondary | Time to hospital discharge (up to Day 30) | 30 days | The time in days required for subjects to be discharged from the first hospitalisation will be estimated and compared between the experimental and placebo groups |
| Secondary | Proportion of subjects admitted to the Intensive Care Unit or High-Dependency Unit (up to Day 30) | 30 days | The number of patients who qualified for admission or where admitted to an intensive care or a high-dependency unit at any time during the first 30 days after entering the study will be estimated and compared between the experimental and placebo groups |
| Secondary | Time until weaning from oxygen therapy (up to Day 30) | 30 days | The time in days subjects required to breathe independently and without oxygen support will be estimated and compared for the experimental and placebo groups |
| Secondary | Time until weaning from respiratory support other than low-flow oxygen supplementation for subjects having developed respiratory failure (up to Day 30) | 30 days | The time in days subjects required to breathe independently with or without supplemental oxygen will be estimated and compared for the experimental and placebo groups |
| Secondary | Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 3 | 3 days | The difference in blood oxygen saturation (SpO2) corrected by the inspired fraction of oxygen (FiO2) between baseline and the time-adjusted average calculated for day 3 will be compared between the experimental and placebo arms |
| Secondary | Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 1 | 1 day | The difference in blood oxygen saturation corrected by the inspired fraction of oxygen between baseline and the time-adjusted average calculated for day 1 will be compared between the experimental and placebo arms |
| Secondary | Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 2 | 2 days | The difference in blood oxygen saturation corrected by the inspired fraction of oxygen between baseline and the time-adjusted average calculated for day 2 will be compared between the experimental and placebo arms |
| Secondary | Proportion of subjects experiencing at least one event of venous thrombosis (specifically deep venous thrombosis or pulmonary embolism) (up to Day 30). | 30 days | The number of patients who developed thrombosis or pulmonary embolism during the first 30 days after entering the study will be estimated and compared between the experimental and placebo groups |
| Secondary | Proportion of subjects by clinical status reported on a 11-point ordinal scale at Day 14 and Day 30 | 14 days and 30 days | The number of patients classified according to an 11-pont scale on their clinical status at day 14 and day 30 will be calculated and compared between the experimental and placebo groups. The 11-point scale is as follows: Uninfected (0 points), Ambulatory and Asymptomatic (1 point), Symptomatic and independent (2 points), Symptomatic requiring assistance (3 points), Hospitalized with no oxygen therapy (4 points), Hospitalized with oxygen by mask or nasal prongs (5 points), Hospitalized with oxygen by non-invasive ventilation or high flow (6 points), Intubation and mechanical ventilation, PaO2/FiO2 ≥ 150 or SpO2/FiO2 ≥ 200 (7 points), Mechanical ventilation, PaO2/FiO2 \<150 (SpO2/FiO2 \< 200) or vasopressors (8 points), Mechanical ventilation, PaO2/FiO2 \< 150 (SpO2/FiO2 \< 200) and vasopressors, dialysis or Extracorporeal Membrane Oxygenation (ECMO) (9 points), Dead (10 points). |
| Secondary | Time to death due to any cause (up to Day 30) | 30 days | For those subjects dying in the first 30 days after study entry, the time from study entry to death will be estimated and compared between the experimental and placebo groups |
| Secondary | All-cause mortality at Day 30 | 30 days | The number of patients dying during the study observation period independent of the cause of death will be calculated and compared between the experimental and placebo groups. |
| Other | Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 14 | 14 days | The difference in blood oxygen saturation corrected by the inspired fraction of oxygen between baseline and the time-adjusted average calculated for day 14 will be compared between the experimental and placebo arms |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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