Trial · NCT04960202
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population | From Day 1 to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic monoclonal antibody (mAb) treatment and were treated \<=3 days of COVID-19 onset. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | Safety analysis set (SAS) included all participants who received at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) | From start of study intervention (Day 1) up to end of safety follow-up (Day 34) | SAS population included all participants who were randomized and took at least one dose of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population | From Day 1 to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. | Percentage of participants | NUMBER |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population | From Day 1 (baseline) to Day 28 | mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 to Day 28 | mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population | From Day 1 (baseline) to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population | From Day 1 (baseline) to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population | From Day 1 (baseline) to Day 28 | mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population | From Day 1 (baseline) to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | From Day 1 (baseline) to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | From Day 1 (baseline) to Day 28 | mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population | From Day 1 (baseline) to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population | From Day 1 (baseline) to Day 28 | mITT1 population included all participants who were randomized and took at least one dose of study intervention and who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population | From Day 1 (baseline) to Day 28 | mITT2 population included all participants who were randomized and took at least one dose of study intervention. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. Here, Number Analyzed signifies participants evaluable for each specified category. | Days | MEDIAN |
| SECONDARY | Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population | From Day 1 (baseline) to Day 28 | mITT population included all participants who were randomized and took at least one dose of study intervention, who at baseline did not receive nor were expected to receive COVID-19 therapeutic mAb treatment and were treated \<=3 days of COVID-19 onset. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | 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.
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