RSV study: Zelicapavir
Official title A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
ClinicalTrials.gov ID: NCT07908381
What this study is testing
What is zelicapavir?
zelicapavir is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for rsv.
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
- Zelicapavir is a novel orally administered non-fusion replication inhibitor of RSV that is being developed for the treatment of patients with RSV infection. This phase 2b/3 study will evaluate the efficacy and safety of zelicapavir compared with placebo in adults with RSV who are at high risk for severe disease.
- Phase 3: a large, late-stage study
- 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
- COPD
- New onset or worsening of preexisting symptoms consistent with respiratory tract infection no more than 72 hours before administration of the first...
- Reports at least 2 of the following symptoms, one of which must be reported by the participant as at least moderate in severity using the RiiQ™...
- Tested positive for RSV infection defined as a positive nucleic acid amplification test (PCR or other) or rapid-antigen viral detection test...
- A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of...
You likely can't join if
- Reported history of respiratory infection (other than RSV) within 7 days prior to signing the ICF.
- Anticipated need for hospitalization within 24 hours of signing the ICF.
- Receiving dialysis or have known severe renal impairment.
- Reported history of chronic liver disease, including cirrhosis, autoimmune hepatitis, end stage liver disease, history of hepatocellular carcinoma...
- Prior receipt of or waiting to receive a bone marrow, stem cell, or solid organ transplant.
See the full eligibility criteria
- COPD
- New onset or worsening of preexisting symptoms consistent with respiratory tract infection no more than 72 hours before administration of the first dose of study intervention: feeling feverish, headache, neck pain...
- Reports at least 2 of the following symptoms, one of which must be reported by the participant as at least moderate in severity using the RiiQ™: cough, cough with phlegm, wheezing, or short of breath.
- Tested positive for RSV infection defined as a positive nucleic acid amplification test (PCR or other) or rapid-antigen viral detection test performed on a nasal swab specimen collected no more than 72 hours before...
- A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
- A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
- Reported history of respiratory infection (other than RSV) within 7 days prior to signing the ICF.
- Anticipated need for hospitalization within 24 hours of signing the ICF.
- Receiving dialysis or have known severe renal impairment.
- Reported history of chronic liver disease, including cirrhosis, autoimmune hepatitis, end stage liver disease, history of hepatocellular carcinoma, or decompensated liver failure.
- Prior receipt of or waiting to receive a bone marrow, stem cell, or solid organ transplant. Currently taking, or has taken within 7 days prior to randomization, or is anticipated to receive during the study, systemic...
The study team makes the final eligibility decision.
Where it is enrolling
- Cape Coral, Florida, United States
- Miami, Florida, United States
- Bluffton, South Carolina, United States
- Brownsville, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but 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?
This study is enrolling now at Cape Coral, Florida, United States; Miami, Florida, United States; Bluffton, South Carolina, United States; Brownsville, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.