What side effects are associated with this type of intervention?

Common treatments for Respiratory Syncytial Virus (RSV) include monoclonal antibodies like palivizumab and investigational agents such as clesrovimab. Known side effects of these treatments can include injection site reactions, fever, and rash. In some cases, more severe adverse events like increased oxygen requirements and pneumothorax have been observed, particularly in intubated and ventilated patients. Overall, these treatments are generally well-tolerated, but monitoring for adverse effects is essential.

What prior FDA approvals exist?

The FDA has approved palivizumab, a monoclonal antibody, for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk. Palivizumab is administered as an intramuscular injection and is typically given to premature infants and children with certain heart and lung conditions. Other treatments for RSV primarily focus on supportive care, as there are limited antiviral options specifically approved for RSV. The ongoing study of Clesrovimab aims to evaluate its safety and tolerability compared to palivizumab, potentially offering another monoclonal antibody option for RSV prevention.

What other types of research exist?

Promising alternatives to Clesrovimab for RSV treatment include Nirsevimab, another monoclonal antibody that has shown efficacy in preventing RSV in infants. Additionally, RSV vaccines such as the Pfizer RSVpreF vaccine and the GSK RSV vaccine are in advanced stages of development and may offer effective prevention options. Antiviral drugs like Ribavirin and new investigational antivirals are also being explored for RSV treatment.

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Monoclonal Antibodies

Clesrovimab for Respiratory Syncytial Virus

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Has severe immunodeficiency or is severely immunocompromised

Has known hepatic or renal dysfunction, or chronic seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from approximately 393 days up to 575 days

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to drug infusion, immune system responses, and potential allergic reactions due to sensitivity to components within clesrovimab or palivizumab.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe immune system problem.

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I have liver, kidney problems, or a chronic seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from approximately 393 days up to 575 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from approximately 393 days up to 575 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from approximately 393 days up to 575 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants with anaphylaxis/hypersensitivity AEs of special interest (AESI) in RSV Season 1

Participants with non-serious AEs in RSV Season 1

Participants with rash AESI in RSV Season 1

+4 more

Secondary study objectives

Concentration of clesrovimab in RSV Season 1

Concentration of clesrovimab in RSV Season 2

Participants with RSV-associated hospitalization in RSV Season 1

+8 more

Side effects data

From 2020 Phase 2 trial • 80 Patients • NCT04086472

38%

Headache

13%

Odynophagia

13%

Rhinorrhoea

Nausea

Upper respiratory tract infection

Nasal injury

C-reactive protein increased

Musculoskeletal pain

Cough

Phlebitis

Neck pain

Oropharyngeal pain

Contusion

Epistaxis

Gastroenteritis

Oral herpes

100%

80%

60%

40%

20%

Study treatment Arm

MK-1654 100 mg

MK-1654 300 mg

MK-1654 200 mg

MK-1654 900 mg

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ClesrovimabExperimental Treatment2 Interventions

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

Group II: PalivizumabActive Control1 Intervention

Participants will receive IM injections.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Clesrovimab

2019

Completed Phase 3

~3900

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies, such as clesrovimab and palivizumab, target specific proteins on the RSV virus, preventing it from entering and infecting human cells. This mechanism is crucial for RSV patients, particularly high-risk infants and children, as it can significantly reduce the severity and duration of the infection. While no curative treatments exist, supportive therapies are also employed to manage symptoms and support respiratory function, highlighting the importance of these targeted therapies in mitigating the impact of RSV.

Pharmacological targets and emerging treatments for respiratory syncytial virus bronchiolitis.New therapies for acute RSV infections: where are we?