Trial · NCT04391309
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Time to Clinical Recovery, Defined as the Time From Baseline to the First Day That Subject is in Categories 1, 2, or 3 on the Eight-Point Ordinal Scale Through Day 28. | Within the 28 day period following baseline | The Primary Endpoint is time to clinical recovery, defined as the time from baseline to the first day that a subject is in categories 1, 2, or 3 on the Eight-Point Ordinal Scale through Day 28 (range 1 \[best\] to 8 \[worst\]). The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day. The Scale is defined as follows: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care 4. Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (COVID-19-related or otherwise) 5. Hospitalized, requiring supplemental oxygen 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 8. Death |
| Secondary | Days Alive and Free of Any Episodes of Acute Respiratory Failure Through Day 28 | Within the 28 day period following baseline. | Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources: 1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4) 2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs 3. Endotracheal intubation and mechanical 4. Extracorporeal membrane oxygenation |
| Secondary | Change in the Ordinal Scale From Baseline to Day 14 | Within the 14 day period following baseline. | A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death. |
| Secondary | Change in Ordinal Scale From Baseline to Day 28. | Within the 28 day period following baseline. | A larger negative change indicates a greater improvement in clinical status from baseline. The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death. |
| Secondary | Ordinal Scale Value on Day 14. | Day 14 following baseline. | The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day (1 is best, 8 is worst). The Scale is defined as follows: 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities and/or requiring home oxygen. 3. Hospitalized, not requiring supplemental oxygen; no longer requires ongoing medical care. 4. Hospitalized, not requiring supplemental oxygen; requiring ongoing medical care (COVID-19-related or otherwise). 5. Hospitalized, requiring supplemental oxygen. 6. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 8. Death. |
| Secondary | All-Cause Mortality Through Day 28. | Within the 28 day period following baseline. | Mortality due to all causes during the observation period. |
| Secondary | All-Cause Mortality Through Day 60. | Within the 60 day period following baseline. | Mortality due to all causes during the observation period. |
| Secondary | Percentage of Participants Alive and Free of Any Episode of Acute Respiratory Failure Through Day 28 | Within the 28 day period following baseline. | Episodes of acute respiratory failure are defined as by need for the following oxygen delivery resources: 1. High-flow nasal cannula (flow rates ≥30L/min with FiO2 ≥0.4) 2. Noninvasive positive-pressure ventilation through nasal or face mask, or nasal plugs 3. Endotracheal intubation and mechanical ventilation 4. Extracorporeal membrane oxygenation |
| Secondary | Days Alive and Free of Invasive Mechanical Ventilation Through Day 28 | Within the 28 day period following baseline. | Endotracheal intubation and mechanical ventilation. |
| Secondary | Percentage of Participants Alive and Free of Invasive Mechanical Ventilation Through Day 28 | Within the 28 day period following baseline. | Endotracheal intubation and mechanical ventilation. |
| Secondary | Percentage of Participants Alive and Discharged From the Hospital Through Day 28 | Within the 28 day period following baseline. | Participants must be alive and discharged from hospital. |
| Secondary | Percent of Participants Who Begin Corticosteroid Therapy for Worsening COVID-19 Illness After Randomization | Within the 28 day period following baseline. | Initiation of corticosteroid therapy. |
| Secondary | Serious Adverse Events (SAEs) | Within the 28 day period following baseline. | Number of serious adverse events |
| Secondary | Adverse Events (AEs) | Within the 28 day period following baseline. | Number of Grade 3 and 4 clinical and/or laboratory adverse events |
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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