Clesrovimab for Respiratory Syncytial Virus
(SMART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the safety and tolerability of a new treatment, clesrovimab, for individuals at high risk of severe respiratory syncytial virus (RSV) infections. It compares clesrovimab to the existing treatment, palivizumab, by monitoring the frequency of side effects in participants. Those recommended to receive palivizumab due to their increased risk of severe RSV may be suitable candidates for this trial. Participants will receive injections of either clesrovimab or palivizumab. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the development of a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that clesrovimab was well-tolerated in previous studies with infants. The FDA approved it for preventing severe respiratory syncytial virus (RSV) in infants, indicating likely safety. In these studies, clesrovimab helped protect against RSV, with few reports of serious side effects. Most participants did not experience severe reactions. While all treatments carry some risks, existing evidence suggests that clesrovimab is generally safe for use in humans.12345
Why do researchers think this study treatment might be promising for respiratory syncytial virus?
Unlike the standard treatment for Respiratory Syncytial Virus (RSV), which typically involves options like palivizumab, clesrovimab stands out due to its novel mechanism of action. Clesrovimab is a monoclonal antibody designed to specifically target and neutralize the RSV virus, potentially offering a more direct and potent approach to tackling the infection. Researchers are excited about clesrovimab because it might provide enhanced protection with intramuscular injections, making it easier to administer while potentially offering longer-lasting effects. This could be especially beneficial for populations at high risk, such as infants and the elderly, who are most vulnerable to severe RSV complications.
What evidence suggests that clesrovimab might be an effective treatment for respiratory syncytial virus?
Research shows that clesrovimab, which participants in this trial may receive, effectively prevents severe respiratory syncytial virus (RSV) in babies. Studies have found that it reduces RSV-related hospital stays by 84% and is 60% effective in preventing RSV itself. The FDA has approved this treatment for preventing RSV in infants, underscoring its strong support from clinical research. In both premature and full-term babies, clesrovimab has significantly reduced the number of medical visits due to RSV. Overall, evidence suggests that clesrovimab is a promising option for reducing RSV complications in young children. Another treatment option in this trial is Palivizumab, which participants may receive as an active comparator.12567
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for infants and children at high risk of severe RSV disease who are recommended to receive palivizumab. Participants must be able to complete follow-up and not have a life expectancy under 6 months, severe immunodeficiency, known organ dysfunction, chronic seizures, hypersensitivity to the drugs tested or require mechanical ventilation at enrollment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intramuscular injections of clesrovimab or palivizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants are monitored for additional safety and efficacy outcomes in RSV Season 2
What Are the Treatments Tested in This Trial?
Interventions
- Clesrovimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University