Trial · NCT03336619
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From First Dose to Symptom Response | Up to 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline. | hours | MEDIAN |
| SECONDARY | Time From First Dose to Ability to Perform All Normal Activities | Up to 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline. | hours | MEDIAN |
| SECONDARY | Number of Subjects Experiencing One or More Complications of Influenza | Up to 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains | Up to 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Time to Return to Usual Health | 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline. | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Proportion of Diaries Misclassified by Novel Response Definition | 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline. Per the Statistical Analysis Plan, the response definition misclassification rate was to be calculated prior to unblinding including all data for subjects in the ITTI population. | diaries | NUMBER |
| POST_HOC | Correlation Coefficient for Sustained Response and Return to Usual Health | 21 days | The correlation coefficient between sustained response and return to usual health was to be calculated prior to unblinding including all data for subjects in the ITTI population, consistent with the misclassification rate as specified in the statistical analysis plan. | correlation coefficient | NUMBER |
| POST_HOC | Time to Return to Usual Health, Placebo-Treated Subjects by Baseline Antibody Status | 21 days | Subjects with laboratory-confirmed influenza (ITTI population) who were randomized to the placebo treatment group by whether the subjects had detectable anti-influenza antibodies at Baseline. | hours | MEDIAN |
| POST_HOC | Time to Sustained Clinical Recovery | 21 days | The ITTI (primary efficacy) population consisted of all subjects positive for influenza by RT-PCR at Baseline. | hours | MEDIAN |
| POST_HOC | Time to Sustained Clinical Recovery by Antibody Status, Placebo-Treated Subjects | 21 days | Placebo-treated subjects with and without anti-influenza antibodies detected at Baseline who were positive for influenza by RT-PCR. | hours | MEDIAN |
| POST_HOC | Time to Sustained Clinical Recovery, Subjects Without Detectable Antibodies at Baseline | 21 days | Subjects positive for influenza by RT-PCR at Baseline with anti-influenza antibodies detected in a Baseline serum sample. | hours | MEDIAN |
| POST_HOC | Time to Sustained Clinical Recovery, mITTI Population Without Detectable Antibodies at Baseline | 21 days | Modified ITTI population consists of subjects with laboratory-confirmed influenza infection without detectable anti-influenza antibodies at Baseline and Baseline subject-reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day. Assessment was completed via the Baseline FLU-PRO questionnaire. | hours | MEDIAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03336619/outcomes