Clesrovimab for Respiratory Syncytial Virus

(SMART Trial)

Recruiting at155 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing two medications, clesrovimab and palivizumab, to see if they are safe and well-tolerated by people who might need them. The study will look at any side effects experienced by participants. Palivizumab is a treatment approved in 1998 for high-risk children against respiratory infections and is now approved in over 45 countries.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

I am at high risk for severe RSV infection and advised to get palivizumab.

Is available to complete the follow-up period

Exclusion Criteria

I have a severe immune system problem.

Requires mechanical ventilation at time of enrollment

Has a life expectancy <6 months

Treatment Details

Interventions

• Clesrovimab (Monoclonal Antibodies)

Trial Overview The study tests the safety of clesrovimab against palivizumab in preventing serious RSV infections in young patients. It measures how many participants experience adverse events with each treatment.

Participant Groups

Group I: Clesrovimab Experimental Treatment 2 Interventions

Participants will receive intramuscular (IM) injections of clesrovimab and placebo

Group II: Palivizumab Active Control 1 Intervention

Participants will receive IM injections.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

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

Trials

4,096

Recruited

5,232,000+

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