Trial · NCT04969991
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 | Proportion of Participants Alive and Free of Respiratory Failure at Day 28 | Baseline to Day 28 | The proportion of respiratory failure-free surviving participants in each Part 2 treatment group at Day 28 will be analyzed using the Mantel-Haenszel stratum-weighted estimator with treatment as a factor. Respiratory failure is defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (\[HFNC\] heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation * ECMO, or * Clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting because of resource limitation) |
| Secondary | Proportion of Subjects Using HFNC Within the First 28 Days After Randomization | From randomization through Day 28 | The proportion of subjects using HFNC within the first 28 days after randomization. |
| Secondary | Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization | From randomization through Day 28 | Proportion of subjects using noninvasive respiratory support within the first 28 days after randomization. |
| Secondary | Proportion of Subjects Using Mechanical Ventilation Within the First 28 Days After Randomization | From randomization through Day 28 | Proportion of subjects using mechanical ventilation within the first 28 days after randomization. |
| Secondary | Number of Days of Oxygen Support Through Day 28 After Randomization | From randomization through Day 28 | Number of days of oxygen support through Day 28 after randomization. |
| Secondary | Proportion of Participants Remaining Free of Mechanical Ventilation or ECMO Throughout the 28 Days After Randomization | From randomization through Day 28 | Proportion of participants remaining free of mechanical ventilation or ECMO throughout the 28 days after randomization. |
| Secondary | Proportion of Subjects With All-cause Mortality Through Day 60 | From randomization through Day 60 | Proportion of subjects who experience all-cause mortality from randomization through Day 60. |
| Secondary | Number of Participants With Change in Body Temperature | From providing informed consent through Day 60 | Number of participants with change in body temperature from providing informed consent through Day 60. |
| Other | Participant-reported Quality-of-life Assessment Using the 12-item Short Form Survey (SF-12) at Day 28 After Randomization | Day 28 | Changes from baseline to Day 28 in SF-12 scores, which range from 0 to 100, with higher scores indicating better physical and mental health functioning. |
| Other | Activity of sPLA2 Within Blood Samples Collected as Clinically Required From Treatment Initiation to Day 28 After Randomization | From treatment initiation through Day 28 | Changes in observed sPLA2 values |
| Other | Changes in PK Parameters: Area-under-the-curve (AUC) | Day 1 through Day 3 | Change in AUC from Day 1 through Day 3 |
| Other | Changes in PK Parameters: Maximum Concentration (Cmax) | Day 1 through Day 3 | Change in Cmax from Day 1 through Day 3 |
| Other | Changes in PK Parameters: Time of Cmax (Tmax) | Day 1 through Day 3 | Change in Tmax from Day 1 through Day 3 |
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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