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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
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:Select...
I have a severe immune system problem.
Select...
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
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 moreSecondary 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 moreSide effects data
From 2020 Phase 2 trial • 80 Patients • NCT0408647238%
Headache
13%
Odynophagia
13%
Rhinorrhoea
6%
Nausea
6%
Upper respiratory tract infection
6%
Nasal injury
6%
C-reactive protein increased
6%
Musculoskeletal pain
6%
Cough
6%
Phlebitis
6%
Neck pain
6%
Oropharyngeal pain
6%
Contusion
6%
Epistaxis
6%
Gastroenteritis
6%
Oral herpes
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-1654 100 mg
MK-1654 300 mg
MK-1654 200 mg
MK-1654 900 mg
Placebo
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
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?
Pharmacological targets and emerging treatments for respiratory syncytial virus bronchiolitis.New therapies for acute RSV infections: where are we?
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,345 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,966 Previous Clinical Trials
5,175,673 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,079,880 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at high risk for severe RSV infection and advised to get palivizumab.I have a severe immune system problem.I have liver, kidney problems, or a chronic seizure disorder.I am in the hospital but expect to be discharged within a week after joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Clesrovimab
- Group 2: Palivizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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