Trial · NCT07881991
Phase 2 Study of SYH2066 Tablets Compared With Placebo in Chinese Adult Patients With Respiratory Syncytial Virus Infection.
NCT07881991, Phase 2, Not yet recruiting, CSPC Ouyi Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of SYH2066 Tablets Compared With Placebo in Chinese Adult Patients With Respiratory Syncytial Virus Infection. Trials, record NCT07881991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07881991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of SYH2066 Tablets Compared With Placebo in Chinese Adult Patients With Respiratory Syncytial Virus Infection.
- NCT number
- NCT07881991
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- SYH2066, Placebo
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07881991
GET https://conductscience.org/api/trials/v1/NCT07881991/registered?page=2