Trial · NCT07881991
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the curve (AUC) of RSV RNA viral load measured by RT-qPCR in nasopharyngeal swab samples | Up to Day 14 | Nasopharyngeal swabs will be taken from Day 1 to Day 14 for RSV RNA quantification, and the area under the RSV RNA load-time curve will be derived from the measured values plotted against time. |
| Secondary | Change from baseline in RSV RNA viral load at each visit （D2, D3, D4, D5, D6, D9, D14, ETV）during the study period | Up to Day 14 | |
| Secondary | Time from first dose to RSV RNA viral load falling below the lower limit of quantification (LLOQ) | Up to Day 14 | |
| Secondary | Percentage of participants with RSV RNA viral load below LLOQ from first dose | Up to Day 14 | |
| Secondary | Area under the curve (AUC) of the Respiratory Infection Severity and Impact Questionnaire score from Day 1 to Day 14 | Up to Day 14 | Participants need complete the RIIQ questionnaire daily from Day 1 through Day 14, and the area under the time-based score curve will be estimated. |
| Secondary | Change from baseline in the Respiratony Infection Severity and lmpact Questionnaire score at each visit (02, D3,D4,D5, D6, D9, D14, ETV) after first dose | Up to Day 14 | Respiratory Infection Severity and Impact Questionnaire(RiiQ questionnaire) is mainly used to assess RSV symptoms in patients, including upper respiratory tract infection symptoms (sore throat and nasal congestion), symptoms of lower respiratory tract infection (cough, wheezing, sputum, shortness of breath), and system symptoms (fever, headache, neck pain, fatigue, lack of appetite, interrupted sleep, body aches). The questionnaire is divided into four grading categories of severity including none (0), mild (1), moderate (2) and severe (3). |
| Secondary | Time from first dose to resolution/recovery of all RSV symptoms | Up to Day 14 | Resolution/recovery of all RSV symptoms is defined as the concurrent fulfillment of all predefined symptom criteria as specified below, with the response sustained for ≥48 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. RSV symptoms include following: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). |
| Secondary | Time from first dose to relief of all RSV symptoms | Up to Day 14 | Relief of all RSV symptoms is defined as the concurrent fulfillment of all predefined symptom criteria as specified below, with the response sustained for ≥48 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. RSV symptoms include following: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). |
| Secondary | Time-weighted average burden of RSV core symptoms (nasal congestion, body aches, sore throat, and cough with phlegm) over 0-96 h post-first dose | Up to Day 14 | It is defined as the AUC of the core symptom burden curve over 0-96 h divided by 96 h, where lower values indicate less overall symptom burden or faster improvement. |
| Secondary | Incidence and severity of adverse events (AEs) | Up to Day 14 | Any abnormalities in vital signs, physical examinations, laboratory tests, 12-lead electrocardiograms (ECGs), or other parameters observed in participants post-dose will be recorded as AEs. |
| Secondary | Time from first dose to resolution/recovery of RSV core symptoms (nasal congestion, body aches, sore throat, cough with phlegm) | Up to Day 14 | Resolution/recovery of RSV core symptoms is defined as the concurrent fulfillment of RSV core symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. |
| Secondary | Time from first dose to resolution/recovery of respiratory symptoms | Up to Day 14 | Resolution/recovery of respiratory symptoms is defined as the concurrent fulfillment of respiratory symptoms criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. Respiratory symptoms include following：stuffy nose, sore throat, cough, expectoration, wheezing, shortness of breath. |
| Secondary | Time from first dose to resolution/recovery of lower respiratory tract symptoms | Up to Day 14 | Resolution/recovery of lower respiratory tract is defined as the concurrent fulfillment of lower respiratory tract symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. Lower respiratory tract symptoms include following: cough, expectoration, wheezing, shortness of breath. |
| Secondary | Time from first dose to resolution/recovery of upper respiratory tract symptoms | Up to Day 14 | Resolution/recovery of upper respiratory tract is defined as the concurrent fulfillment of upper respiratory tract symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. Upper respiratory tract symptoms include following: stuffy nose, sore throat. |
| Secondary | Time from first dose to resolution/recovery of systemic symptoms | Up to Day 14 | Resolution/recovery of systemic symptoms is defined as the concurrent fulfillment of systemic symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0; * For symptoms present before infection: return to pre-infection level or better. Systemic symptoms include following: feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite. |
| Secondary | Time from first dose to relief of RSV core symptoms (nasal congestion, body aches, sore throat, cough with phlegm) | Up to Day 14 | Relief of RSV core symptoms is defined as the concurrent fulfillment of RSV core symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. |
| Secondary | Time from first dose to relief of respiratory symptoms | Up to Day 14 | Relief of respiratory symptoms is defined as the concurrent fulfillment of respiratory symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. Respiratory symptoms include following: stuffy nose, sore throat, cough, expectoration, wheezing, shortness of breath. |
| Secondary | Time from first dose to relief of lower respiratory tract symptoms | Up to Day 14 | Relief of lower respiratory tract symptoms is defined as the concurrent fulfillment of lower respiratory tract symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. Lower respiratory tract symptoms include following: cough, expectoration, wheezing, shortness of breath. |
| Secondary | Time from first dose to relief of upper respiratory tract symptoms | Up to Day 14 | Relief of upper respiratory tract symptoms is defined as the concurrent fulfillment of upper respiratory tract symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. Upper respiratory tract symptoms include following: stuffy nose, sore throat. |
| Secondary | Time from first dose to relief of systemic symptoms | Up to Day 14 | Relief of systemic symptoms is defined as the concurrent fulfillment of systemic symptom criteria as specified below, with the response sustained for ≥24 hours: * For symptoms not present before infection: reduction to a score of 0 or 1; * For symptoms present before infection and worsened by the current RSV infection: improvement of at least 1 point from baseline (pre-treatment); * For symptoms present before infection but not worsened by the current infection: maintained at pre-infection level or better. Systemic symptoms include following: feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite. |
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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