Trial · NCT04467840
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Supplemental Oxygen Requirement | 14 days maintained up to 42 days | Modified ITT (mITT) population defined as randomized subjects who received at least one dose of study medication | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42 | 14 days maintained up to 42 days | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0 | 14 days maintained up to 42 days | mITT population presenting subjects who experienced a recovery event by Day 14 maintained up to day 42 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Low Oxygen Flow Via Nasal Cannula | 14 days maintained up to 42 days | mITT. In this analysis, subjects who required low-flow supplemental oxygen at Day 1 (baseline) were considered success events, and the time to event of interest for these subjects was defined as 0. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Discharge From Hospital Measured at 14 Days | 14 days | mITT | Days | MEDIAN |
| SECONDARY | Patients Requiring Intubation and Mechanical Ventilation by Day 42 | 42 days | Subjects requiring intubation by Day 42 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14 | 14 days | Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit were analyzed | participants | NUMBER |
| SECONDARY | Patients With Negative Swabs for SARS-CoV-2 at Day 14 | 14 days | Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit AND had at least two post baseline PCR tests were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality Due to Any Cause | 28 days | Mortality (failure) was assessed by treatment Day 28 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mortality Due to Any Cause | 42 days | Mortality (failure) was assessed by treatment Day 42 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From first dose until 4 weeks follow-up after the end of treatment | TEAE=Treatment emergent adverse event. Treatment emergent events are events that started on or after the date of first dose | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Supplemental Oxygen Requirement in the ≤60% FiO2 Sub-population | Day 14 | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Supplemental Oxygen Requirement in the > 60% FiO2 Sub-population | Day 14 | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Subjects With ≥ 2 Category Improvement on the WHO Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42 in the FiO2 ≤ 60% Population | 14 days maintained up to 42 days or classified as a failure | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Subjects With ≥ 2 Category Improvement on the WHO Ordinal Scale for Clinical Improvement by Day 14 up to Day 42 in the FiO2 > 60% Population | 14 days maintained up to 42 days or classifed as failure | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 ≤60% Population | 14 days | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 > 60% Population | 14 days | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Subjects Discharged From Hospital in the FiO2 ≤60% Population | 14 days | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Subjects Discharged From Hospital in the FiO2 > 60% Population | 14 days | A post hoc analysis set comprised two sub-populations, namely, lower FiO2 (FiO2 at baseline ≤ the median of 60%) and higher FiO2 (FiO2 at baseline \> the median of 60%) was added after the final version of the SAP was signed. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Requiring Intubation and Mechanical Ventilation by Day 42 in the FiO2 ≤60% Population | 42 days | Subjects requiring intubation by Day 42 in the FiO2 ≤60% sub-population | Participants | COUNT_OF_PARTICIPANTS |
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/NCT04467840/outcomes