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: Completed; Phase 3

Conditions: RSV Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04938830

jRCT2031210664 (Registry Identifier)

MK-1654-007 (Other Identifier)

2022-500752-39-00 (Registry Identifier)

U1111-1278-0093 (Registry 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: 1,003 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 and meet defined criteria for the Early or Moderate Pre-term Group or the chronic lung disease (CLD)/congenital heart disease (CHD) Group.
• Is available to complete the follow-up period.

Additional inclusion criteria for participation in RSV Season 2:

• RSV Season 2 participants enrolled in the CLD/CHD Group in RSV Season 1. Participants with CHD must also have the following:

  • Hemodynamically significant CHD at the beginning of RSV Season 2, or
  • If the participant has had surgically repaired hemodynamically significant CHD that did not include extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass: 1) continues to require medications to manage CHD, or 2) any additional medical intervention related to their CHD.

• RSV Season 2 participants enrolled in the Early or Moderate Pre-term Group in RSV Season 1, with the following:

  • Neuromuscular disease or congenital pulmonary anomaly that impairs the ability to clear secretions from the upper airway because of ineffective cough
  • Down Syndrome (trisomy of chromosome 21)
  • Cystic fibrosis with nutritional compromise
  • Native Americans and Alaskan Indians or other indigenous populations at high risk for severe RSV disease

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.

Additional exclusion criteria for participation in RSV Season 2:

• Had 1) ECMO or 2) surgical intervention during the RSV season for CHD and required cardiopulmonary bypass during the procedure in RSV Season 1.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,003 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