Trial · NCT05011513
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | Modified intent-to-treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Days | MEDIAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation | From start of study intervention (Day 1) up to Day 34 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 | From Day 1 to Day 28 | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Death Through Week 24 | From Day 1 to Week 24 | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Number of COVID-19 Related Medical Visits Per Day Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Medical visits per day | LEAST_SQUARES_MEAN |
| SECONDARY | Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Days | MEAN |
| SECONDARY | Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. In this outcome measure time to sustained resolution is reported consolidated for overall COVID-19 signs and symptoms. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Days | MEDIAN |
| SECONDARY | Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Number Analyzed'' signifies participants evaluable at specific rows. | Days | MEDIAN |
| SECONDARY | Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28 | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms | From Day 1 to Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5 | Day 1 and Day 5 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Percentage of participants | NUMBER |
| SECONDARY | Plasma Concentration Versus Time Summary of PF-07321332 | Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Nanograms per milliliter | MEAN |
| SECONDARY | Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14 | Baseline, Days 3, 5, 10 and 14 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Log 10 copies per milliliter | LEAST_SQUARES_MEAN |
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
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