Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) (SMART)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: RSV Infection

Treatments: Biological: Placebo; Biological: Palivizumab; Biological: Clesrovimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04938830

jRCT2031210664 (Registry Identifier)

MK-1654-007 (Other Identifier)

2020-005996-11 (EudraCT Number)

1654-007

Details and patient eligibility

About

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
• Is available to complete the follow-up period.

Exclusion criteria

• Requires mechanical ventilation at time of enrollment.
• Has a life expectancy <6 months.
• Has known hepatic or renal dysfunction, or chronic seizure disorder.
• Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
• Has severe immunodeficiency or is severely immunocompromised.
• Has known hypersensitivity to any component of clesrovimab or palivizumab.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

Clesrovimab

Experimental group

Description:

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

Treatment:

Biological: Clesrovimab

Biological: Placebo

Palivizumab

Active Comparator group

Description:

Participants will receive IM injections.

Treatment:

Biological: Palivizumab