Trial · NCT05047601
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| 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 end of safety follow-up (Day 38) | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure. |
| Secondary | Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness | From Day 1 to Day 14 | Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness | From Day 1 to Day 28 | The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. |
| Secondary | Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure. |
| Secondary | Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline | From Day 1 to Day 14 | Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline | From Day 1 to Day 14 | Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19. |
| Secondary | Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. |
| Secondary | Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28. |
| Secondary | Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332) | Day 1: 1 hour post dose; Day 5: 2 hours pre-dose | |
| Secondary | Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 38 | Percentage of participants with death (all-cause) event were reported in this outcome measure. |
| Secondary | Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 14 | Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure. |
| Secondary | Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline | From Day 1 to Day 14 | Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure. |
| Secondary | Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day. |
| Secondary | Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline | From Day 1 to Day 28 | In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing. |
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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