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New treatment option for Respiratory Syncytial Virus Infections
Official title A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
ClinicalTrials.gov ID: NCT07214571
What this study is testing
What is S-337395?
S-337395 is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral...
- Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.
- Has at least 1 of the following risk factors for severe RSV disease:
- ≥ 75 years of age;
- Chronic lung disease that is symptomatic and requiring chronic treatment; and
You likely can't join if
- Hospitalized or expected to be hospitalized within 24 hours of screening.
- Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem...
- Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.
- Suspicion or known severe renal impairment.
- Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to...
- Has received a therapy intended to treat RSV infection within 14 days prior to screening.
See the full eligibility criteria
- Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization...
- Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay.
- Has at least 1 of the following risk factors for severe RSV disease:
- ≥ 75 years of age;
- Chronic lung disease that is symptomatic and requiring chronic treatment; and
- Chronic cardiovascular disease that is symptomatic and requiring chronic treatment.
- With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Key
- Hospitalized or expected to be hospitalized within 24 hours of screening.
- Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant.
- Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation.
- Suspicion or known severe renal impairment.
- 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...
- Has received a therapy intended to treat RSV infection within 14 days prior to screening.
- Is receiving chemotherapy or immunotherapy for malignancy.
- Has received RSV vaccination within 7 days prior to screening.
- Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening.
- Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening. Note: Other protocol-specified inclusion and exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Toluca Lake, California, United States
- Coral Gables, Florida, United States
- Cutler Bay, Florida, United States
- Hialeah, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- North Miami Beach, Florida, United States
- Port Saint Lucie, Florida, United States
- Sweetwater, Florida, United States
- Tampa, Florida, United States
- East Point, Georgia, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- The Bronx, New York, United States
- Winston-Salem, North Carolina, United States
- Cleveland, Ohio, United States
- Chickasha, Oklahoma, United States
- Providence, Rhode Island, United States
- DeSoto, Texas, United States
+ 46 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Toluca Lake, California, United States; Coral Gables, Florida, United States; Cutler Bay, Florida, United States; Hialeah, Florida, United States; Miami, Florida, United States and 60 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.