BridgeMD
Phase 2b study of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus (RSV) who are at high risk of progression to severe disease
EU CTIS ID: 2025-523156-31-00
What this study is testing
To investigate the antiviral effect of S-337395 in participants with RSV infection
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 1. Participant must be ≥ 18 years of age (or the minimum age of informed consent if the minimum age of informed consent determined by local regulations is >18 years) at the time of screening.
- Type of Participant and Disease Characteristics 3. Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay. Note: If a participant had a positive RSV test result using a molecular-based diagnostic assay from another study for which he/she was otherwise ineligible or from a standard-of-care molecular-based diagnostic test within 72 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for determination of eligibility. 5. With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and/or the RSV infection.
- Sex and Contraceptive/Barrier Requirements The following criteria apply to male and female participants: 6. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Men must refrain from semen donation a. Male participants: Male participants are eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of investigational intervention: ● Refrain from donating fresh unwashed semen PLUS either: ● Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR ● Must agree to use contraception/barrier as detailed below – Agree to use a male condom when having sexual intercourse with a woman of childbearing potential who is not currently pregnant – Agree to use a male condom when engaging in any activity allowing for passage of ejaculate to another person
- Informed Consent 7. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Each participant has signed an ICF indicating he/she: a. Understands the purpose of, and procedures required for, the study b. Is willing and able to adhere to the prohibitions and restrictions with respect to the concomitant medication c. Is willing and able to adhere to the study procedures and assessments to be performed
You likely can't join if
- 1. Hospitalized or expected to be hospitalized within 24 hours of screening. Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study.
- Prior/Concomitant Therapy 13. Has received a therapy intended to treat RSV infection (eg, ribavirin, traditional Chinese medicines, or complementary therapies) within 14 days prior to screening
- 14. Is receiving chemotherapy or immunotherapy for malignancy
- 15. Has received RSV vaccination within 7 days prior to screening Note: RSV vaccination is not prohibited, unless administered within 7 days prior to screening.
- Prior/Concurrent Clinical Study Experience 16. The participant is currently participating or planned to participate in another clinical interventional study, during their participation in this study.
- Diagnostic Assessments 17. Has had either confirmed SARS-CoV-2 or influenza infection (test was positive) during the 28 days prior to screening,
See the full eligibility criteria
Who can join
- Age 1. Participant must be ≥ 18 years of age (or the minimum age of informed consent if the minimum age of informed consent determined by local regulations is >18 years) at the time of screening.
- Type of Participant and Disease Characteristics 3. Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay. Note: If a participant had a positive RSV test result using a molecular-based diagnostic assay from another study for which he/she was otherwise ineligible or from a standard-of-care molecular-based diagnostic test within 72 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for determination of eligibility. 5. With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and/or the RSV infection.
- Sex and Contraceptive/Barrier Requirements The following criteria apply to male and female participants: 6. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Men must refrain from semen donation a. Male participants: Male participants are eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of investigational intervention: ● Refrain from donating fresh unwashed semen PLUS either: ● Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR ● Must agree to use contraception/barrier as detailed below – Agree to use a male condom when having sexual intercourse with a woman of childbearing potential who is not currently pregnant – Agree to use a male condom when engaging in any activity allowing for passage of ejaculate to another person
- Informed Consent 7. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Each participant has signed an ICF indicating he/she: a. Understands the purpose of, and procedures required for, the study b. Is willing and able to adhere to the prohibitions and restrictions with respect to the concomitant medication c. Is willing and able to adhere to the study procedures and assessments to be performed
What rules you out
- 1. Hospitalized or expected to be hospitalized within 24 hours of screening. Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study.
- Prior/Concomitant Therapy 13. Has received a therapy intended to treat RSV infection (eg, ribavirin, traditional Chinese medicines, or complementary therapies) within 14 days prior to screening
- 14. Is receiving chemotherapy or immunotherapy for malignancy
- 15. Has received RSV vaccination within 7 days prior to screening Note: RSV vaccination is not prohibited, unless administered within 7 days prior to screening.
- Prior/Concurrent Clinical Study Experience 16. The participant is currently participating or planned to participate in another clinical interventional study, during their participation in this study.
- Diagnostic Assessments 17. Has had either confirmed SARS-CoV-2 or influenza infection (test was positive) during the 28 days prior to screening,
- 18. Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening
- Other Exclusion Criteria 19. Women who are of childbearing potential
- 20. Men who plan to father a child while enrolled in this study or within 10 days after the last dose of study intervention
- 21. Participants unable to take medications orally or with a known gastrointestinal-related condition considered by the sponsor or investigator to be likely to interfere with study intervention ingestion or absorption
- 22. Participants unwilling to undergo nasal nasopharyngeal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens
- 2. Is considered by the investigator to be immunocompromised, due to an underlying medical condition (eg, HIV infection, malignancy, or genetic disorder other than immunoglobulin A deficiency) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of COPD or asthma exacerbations), chemotherapy, radiation, stem cell or solid organ transplant
- 23. At the US sites, site staff and their families who are directly involved in the conduct of the study, site staff who are otherwise under the supervision of the investigator, and sponsor and sponsor representative employees and their families who are directly involved in the conduct of this study. For sites in all other countries, apply local country regulations.
- 3. Major surgery within 28 days prior to enrolment in the study or planned major surgery during the study
- 4. Has a neuromuscular disease affecting swallowing or the thoracic muscles
- 5. Has a known or clinically suspected acute or chronically active hepatitis B or C infection
- 6. Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation
- 7. Suspicion or known severe renal impairment (defined as estimated glomerular filtration rate < 30 mL/min/1.73 m2) or ongoing dialysis
- 8. Aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN (except for Gilbert syndrome) within the past 3 months, active liver disease (except direct bilirubin > ULN), or the presence of liver dysfunction grade B or C according to the Child-Pugh classification
- 9. Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator/subinvestigator
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- United States
- Vietnam
- Taiwan
- Japan
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; United States; Vietnam; Taiwan; Japan; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.