Trial · NCT05559905
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Panel A vs Panel C: Peak Viral Load (PVL) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | PVL was defined as the maximum viral load during a specified time period. PVL determined by viral quantitative culture (plaque assay) was measured from Day 2 up to Day 12 (end of participant quarantine). PVL (on the log10 scale) of RSV A Memphis 37b determined by viral quantitative culture (plaque assay) between Day 2 and Day 12 am after intranasal inoculation (Day 0) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Primary | Panel B vs. Panel C: Area Under the Viral Load-time Curve (VL-AUC) Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by viral quantitative culture (plaque assay) from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Adverse Event (AE) | From Day -1 up to Day 28 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced an AE is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Serious AE (SAE) | From Day -1 up to Day 28 | An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly or birth defect; or is another important medical event such as invasive/malignant cancers or substance abuse/dependency. The number of participants who experienced an SAE is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related AE | From Day 0 up to Day 28 | A viral challenge-related AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that was considered related to the viral challenge (inoculation). The number of participants who experienced AEs related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up is reported. |
| Secondary | All Panels: Number of Participants Who Experienced ≥1 Viral Challenge-Related SAE | From Day 0 up to Day 28 | A viral challenge-related SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required hospitalization or prolonged existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly or birth defect; or was another important medical event, that was considered related to the viral challenge (inoculation). The number of participants who experienced SAEs related to the viral challenge from viral challenge (Day 0) up to the Day 28 follow-up is reported. |
| Secondary | All Panels: Number of Participants Using Concomitant Medications From Viral Challenge Through Day 28 | From Day 0 up to Day 28 | Concomitant medications were defined as any prescription medications, over the counter drugs or dietary supplements that a participant happened to be taking while on study, in addition to molnupiravir. The number of participants using concomitant medications from viral challenge (Day 0) up through Day 28 is reported. |
| Secondary | Panel A vs. Panel C: VL-AUC Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by viral quantitative culture (plaque assay) from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Secondary | Panel A vs. Panel C: VL-AUC Determined by Real-time Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) | Day 2 up through Day 12 | VL-AUC between Day 2 and Day 12 after intranasal inoculation (Day 0) was computed for each participant, based on RSV viral load determined by qRT-PCR from nasal wash samples collected twice daily (morning and evening). In order to calculate the AUC, the actual time that the assessment was collected was used within the AUC calculation. VL-AUC (on the log10 scale) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Secondary | Panel A vs. Panel C: PVL Determined by qRT-PCR | Day 2 up through Day 12 | PVL was defined as the maximum viral load during a specified time period. PVL as determined by qRT-PCR was measured starting from Day 2 up to planned discharge from quarantine (Day 12 am). Nasal wash samples were collected and tested for RSV viral load by qRT-PCR twice daily from Day 2 through Day 11. A single nasal wash sample for RSV viral load by qRT-PCR was collected on Day 12. PVL by qRT-PCR was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. |
| Secondary | Panel A vs. Panel C: Area Under the Curve Over Time of Total Symptom Scores (TSS-AUC) | From Day -1 up to Day 12 | Participants used a symptom diary card to record the daily severity of 10 clinical symptoms on a scale ranging from 0 ("no symptoms") to 3 ("bothersome and interferes with activities"), with the exception of "shortness of breath" symptom which was scored from 0 ("no symptoms") to 4 ("symptoms at rest"). Total symptom scores (TSS) ranged from 0 to 31, with higher scores indicating greater symptom severity. TSS were used to calculate the AUC for each participant based on the available non-missing calculated total symptom scores between Day -1 until Day 12 (quarantine discharge) using the Trapezoidal rule. TSS-AUC was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. TSS-AUC measured from 10 symptoms within the graded symptom scoring was reported. |
| Secondary | Panel A vs. Panel C: Area Under the Curve Over Time of Total Symptom Scores Change From Baseline (TSS-AUC-CFB) | Baseline (Day -1) and up to Day 12 | Participants used a symptom diary card to record the daily severity of 10 clinical symptoms on a scale ranging from 0 ("absence") to 3 ("bothersome and interferes with activities"), with the exception of "shortness of breath" symptom which was scored from 0 ("no symptoms") to 4 ("symptoms at rest"). TSS ranged from 0 to 31, with higher scores indicating greater symptom severity. TSS were used to calculate the AUC for each participant based on the available non-missing calculated total symptom scores between Day -1 until Day 12 (quarantine discharge) using the Trapezoidal rule. TSS-AUC-CFB was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. TSS-AUC-CFB was defined as the change from baseline in TSS-AUC from Day -1 up to Day 12. TSS-AUC-CFB measured from 10 symptoms within the graded symptom scoring was reported. |
| Secondary | Panel A vs. Panel C: Peak Total Symptom Scores | From Day -1 up to Day 12 | Participants used a symptom diary card to record the daily severity of 10 clinical symptoms on a scale ranging from 0 ("no symptoms") to 3 ("bothersome and interferes with activities"), with the exception of "shortness of breath" symptom which was scored from 0 ("no symptoms") to 4 ("symptoms at rest"). TSS ranged from 0 to 31, with higher scores indicating greater symptom severity. The highest TSS (defined as the sum of all 10 individual composite symptoms) was summarized by treatment group and analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. Peak TSS measured from 10 symptoms within the graded symptom scoring was reported. |
| Secondary | Panel A vs. Panel C: Peak Daily Symptom Score | From Day 2 up to Day 12 | Participants used a symptom diary card to record the daily severity of 10 clinical symptoms on a scale ranging from 0 ("no symptoms") to 3 ("bothersome and interferes with activities"), with the exception of "shortness of breath" symptom which was scored from 0 ("no symptoms") to 4 ("symptoms at rest"). TSS ranged from 0 to 31, with higher scores indicating greater symptom severity. The highest total symptom score recorded on each day, across the three assessments, for each participant was summarized descriptively by treatment group and assessment day. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. Peak daily sums of symptom score measured from 10 symptoms within the graded symptom scoring were reported for Panels A and C. |
| Secondary | Panel A vs. Panel C: Percentage of Participants With Respiratory Syncytial Virus (RSV) Infection Based on qRT-PCR | From Day 2 up to Day 12 | A qRT-PCR-confirmed RSV infection was defined as 2 quantifiable (≥ lower limit of quantification \[LLOQ\]) qRT-PCR measurements (reported on 2 or more independent samples over 2 days), from Day 2 up to Day 12. The number of participants with qRT-PCR-confirmed RSV infection is reported. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. |
| Secondary | Panel A vs. Panel C: Percentage of Participants With RSV Infection Based on Cell Culture Measurement of Nasal Sample | From Day 2 up to Day 12 | RSV infection based on cell culture measurement was defined as at least one positive (≥ LLOQ) cell culture measurement in nasal swab samples. The percentage of participants with at least one positive (≥ LLOQ) cell culture measurement in nasal swab samples is reported. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. |
| Secondary | Panel A vs. Panel C: Percentage of Participants With qRT-PCR Confirmed Symptomatic RSV Infection | From Day 2 up to Day 12 | Symptomatic RSV infection was defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements reported on 2 or more days and either one or more clinical symptoms of any grade from two different categories in the symptom scoring system (upper respiratory, lower respiratory, systemic) or one grade 2 symptom from any category. The percentage of participants with qRT-PCR-confirmed symptomatic RSV infection is reported. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. |
| Secondary | Panel A vs. Panel C: Percentage of Participants With qRT-PCR Confirmed Moderately Severe Symptomatic RSV Infection | From Day 2 up to Day 12 | Moderately severe symptomatic RSV infection was defined as 2 quantifiable (≥LLOQ) qRT-PCR measurements reported on 2 or more consecutive days and any symptom scores of grade ≥2 at a single time point. The percentage of participants with qRT-PCR-confirmed moderately severe symptomatic RSV infection is reported. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. |
| Secondary | Panel A vs. Panel C: Percentage of Participants With Culture-Confirmed Symptomatic RSV Infection | From Day 2 up to Day 12 | Culture-confirmed symptomatic RSV infection was defined by 1 quantifiable (≥LLOQ) cell culture measurement from Day 2 up to Day 12, and either one or more clinical symptoms of any grade from two different categories in the symptom scoring system (upper respiratory, lower respiratory, systemic) or one grade 2 symptom from any category. The percentage of participants with culture confirmed symptomatic RSV infection is reported. Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the analysis. |
| Secondary | Panel B vs. Panel C: PVL Determined by Viral Quantitative Culture | From Day 2 up to Day 12 | PVL was defined as the maximum viral load during a specified time period. PVL as determined by viral quantitative culture was measured starting from Day 2 up to planned discharge from quarantine (Day 12 am). PVL (on the log10 scale) of RSV A Memphis 37b determined by viral quantitative culture (plaque assay) between Day 2 and Day 12 am after intranasal inoculation (Day 0) was analyzed using a linear model with treatment group as a fixed categorical effect. Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. |
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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