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Monoclonal Antibodies

Clesrovimab for Respiratory Syncytial Virus

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from approximately 393 days up to 575 days
Awards & highlights

Study Summary

This trial is testing if a new drug is safe and if people can tolerate it. They will compare it to another drug to see if it causes fewer side effects.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Rhinorrhoea
13%
Odynophagia
6%
Upper respiratory tract infection
6%
Cough
6%
Musculoskeletal pain
6%
C-reactive protein increased
6%
Neck pain
6%
Oropharyngeal pain
6%
Contusion
6%
Nasal injury
6%
Nausea
6%
Epistaxis
6%
Gastroenteritis
6%
Oral herpes
6%
Phlebitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-1654 100 mg
MK-1654 200 mg
MK-1654 300 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 2
~270
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,820 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,868 Previous Clinical Trials
5,050,853 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,770 Previous Clinical Trials
8,060,966 Total Patients Enrolled

Media Library

Clesrovimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04938830 — Phase 3
Respiratory Syncytial Virus Research Study Groups: Clesrovimab, Palivizumab
Respiratory Syncytial Virus Clinical Trial 2023: Clesrovimab Highlights & Side Effects. Trial Name: NCT04938830 — Phase 3
Clesrovimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938830 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what ways has MK-1654 been shown to be harmful?

"There is some clinical evidence to support the efficacy of MK-1654, as well as data from multiple rounds of testing that vouch for its safety. Consequently, our team at Power has given it a safety rating of 3."

Answered by AI

What do we know about MK-1654 from other scientific research?

"The first MK-1654 trial was conducted in 2019 at Research Site. Since then, there have been a total of 18249 completed studies. Currently, there are 3 trials recruiting patients, and many of these are located in Spokane, Washington."

Answered by AI

What is the proposed outcome of this research?

"The primary objective of this clinical trial, as reported by sponsor Merck Sharp & Dohme Corp., is to measure the number of participants with serious adverse events (SAEs) during their RSV Season 1 participation. This trial will also assess secondary outcomes including the concentration of MK-1654 in RSV Season 2, the concentration of MK-1654 in RSV Season 1, and the percentage of participants with rash AESI in RSV Season 2."

Answered by AI

How many individuals are eligible to receive this experimental treatment?

"In order to successfully complete this study, we require the recruitment of one thousand patients that fit the predetermined criteria. These patients can be drawn from locations such as Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030) in Spokane, Washington and CHU Sainte-Justine ( Site 0178) in Montréal, Quebec."

Answered by AI

How many different hospitals or medical centers are conducting this research project?

"This clinical trial is being offered at 22 sites, some of which include Providence Sacred Heart Medical Center & Children's Hospital ( Site 0030) in Spokane, CHU Sainte-Justine ( Site 0178) in Montréal, and University of South Florida-Department of Pediatrics ( Site 0045) in Tampa."

Answered by AI

To your knowledge, is this research novel in its field?

"3 ongoing studies for MK-1654 are occurring in 111 global cities and 36 nations. The inaugural clinical trial for MK-1654 was in 2019. That year, MedImmune LLC sponsored a 925 person study that completed its Phase 2 & 3 drug approval process. Since 2019, a total of 18249 trials have been carried out."

Answered by AI
~333 spots leftby Jun 2025