Clesrovimab for Respiratory Syncytial Virus

(SMART Trial)

Recruiting at 155 trial locations

Overseen By Toll Free Number

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Palivizumab

Disqualifiers: Mechanical ventilation, Life expectancy <6 months, Hepatic or renal dysfunction, Chronic seizure disorder, Severe immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 42 days

1003 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Clesrovimab for Respiratory Syncytial Virus?

Clesrovimab is similar to other monoclonal antibodies like palivizumab, which has been shown to reduce hospitalizations due to RSV in high-risk infants by 55%. This suggests that Clesrovimab might also be effective in preventing RSV infections. ^{1 2 3 4 5}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections of clesrovimab or palivizumab

Up to 42 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 365 days

Extension

Participants are monitored for additional safety and efficacy outcomes in RSV Season 2

From approximately 393 days up to 575 days

Treatment Details

Interventions

• Clesrovimab

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. [2022]

2. France pubmed.ncbi.nlm.nih.gov

Quantification of clesrovimab, an investigational, half-life extended, anti-respiratory syncytial virus protein F human monoclonal antibody in the nasal epithelial lining fluid of healthy adults. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Expected Impact of Universal Immunization With Nirsevimab Against RSV-Related Outcomes and Costs Among All US Infants in Their First RSV Season: A Static Model. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Prevention of respiratory syncytial virus infections in high-risk infants by monoclonal antibody (palivizumab). [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group. [2019]