A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus who are at high risk of progression to severe disease

Conditions

Respiratory Syncytial Virus

Brief summary

Change from baseline in RSV RNA load by qRT-PCR (nasopharyngeal swab) on visit 2 (day 2), visit 3 (day 4), and visit 4 (day 6)

Detailed description

Assessment of TEAEs, clinical laboratory test results, 12-lead ECGs, physical examination findings, and vital signs measurements, Change from baseline over time in severity of RSV symptoms using RiiQ™: respiratory (RiiQ-RSS), systemic (RiiQ-SSS), and total (RiiQ-RSS + RiiQ-SSS). Time to resolution defined as return to baseline per PSQ. Includes time to first and sustained (2 days) resolution of respiratory, systemic, and combined symptoms, and resolution of each symptom separately, based on RiiQ subscales., Based on RSV virological assay (nasopharyngeal swabs): Change from baseline in RSV RNA load and infectious titer at each time point; AUC through day 6; time to first/sustained negative or , > Plasma concentrations of S-337395 after repeated oral doses of S-337395 > Plasma concentrations of S 337395 12 and 24 hours after the first dose and the last dose (C12 and C24)

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in RSV RNA load by qRT-PCR (nasopharyngeal swab) on visit 2 (day 2), visit 3 (day 4), and visit 4 (day 6)	—

Secondary

Measure	Time frame
Assessment of TEAEs, clinical laboratory test results, 12-lead ECGs, physical examination findings, and vital signs measurements, Change from baseline over time in severity of RSV symptoms using RiiQ™: respiratory (RiiQ-RSS), systemic (RiiQ-SSS), and total (RiiQ-RSS + RiiQ-SSS). Time to resolution defined as return to baseline per PSQ. Includes time to first and sustained (2 days) resolution of respiratory, systemic, and combined symptoms, and resolution of each symptom separately, based on RiiQ subscales., Based on RSV virological assay (nasopharyngeal swabs): Change from baseline in RSV RNA load and infectious titer at each time point; AUC through day 6; time to first/sustained negative or , > Plasma concentrations of S-337395 after repeated oral doses of S-337395 > Plasma concentrations of S 337395 12 and 24 hours after the first dose and the last dose (C12 and C24)	—

Measure

Time frame

Assessment of TEAEs, clinical laboratory test results, 12-lead ECGs, physical examination findings, and vital signs measurements, Change from baseline over time in severity of RSV symptoms using RiiQ™: respiratory (RiiQ-RSS), systemic (RiiQ-SSS), and total (RiiQ-RSS + RiiQ-SSS). Time to resolution defined as return to baseline per PSQ. Includes time to first and sustained (2 days) resolution of respiratory, systemic, and combined symptoms, and resolution of each symptom separately, based on RiiQ subscales., Based on RSV virological assay (nasopharyngeal swabs): Change from baseline in RSV RNA load and infectious titer at each time point; AUC through day 6; time to first/sustained negative or , > Plasma concentrations of S-337395 after repeated oral doses of S-337395 > Plasma concentrations of S 337395 12 and 24 hours after the first dose and the last dose (C12 and C24)

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Countries

Bulgaria

Outcome results