Trial · NCT04414618
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Measurement of the Change in Oxygen Requirement From Baseline | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | L/min*day | MEDIAN |
| SECONDARY | Measurement of Time to the Reduction in Oxygen Requirement. | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis. | Days | MEDIAN |
| SECONDARY | The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment | 6 weeks | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses. | Days | MEDIAN |
| SECONDARY | The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, as most subjects had been discharged by Day 7 and as the study was not designed to be performed on an outpatient basis, data was not available from enough subjects to perform these analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intubation and Mechanical Ventilation Requirements | From screening phase and every day from day 1 to day 14 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of the Time to Intubation and Mechanical Ventilation | From screening phase and every day from day 1 to day 14 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Days | MEDIAN |
| SECONDARY | Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14 | From screening phase and every day from day 1 to day 14 of treatment | Patients in the Modified ITT (mITT) population (randomized and treated with at least one dose of study medication) with at least one measurement of fever at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluation of Mortality 30 Days Post-baseline | 30 days after day 1 of treatment | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety TEAEs | 6 weeks | Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Safety SAEs | 6 weeks | Safety population includes all subjects randomized and treated with at least one dose of study medication. One subject randomized to receive placebo, was mistakenly given 2 doses of opaganib and is therefore included twice. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Percent Change in Measurement of the Daily Oxygen Requirement | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis. | Percentage of change from baseline*day | MEDIAN |
| POST_HOC | Measurement of the Relative Benefit for Each Treatment Are as Derived From Oxygen Requirements | 14 days | Modified ITT (mITT) population (randomized and treated with at least one dose of study medication). However, one subject who did not have supplemental oxygen requirement at randomization was excluded from this analysis. | Percentage of relative benefit | NUMBER |
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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GET https://conductscience.org/api/trials/v1/NCT04414618/outcomes