Your session is about to expire
← Back to Search
Monoclonal Antibodies
Clesrovimab for Respiratory Syncytial Virus
Phase 2 & 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
For the phase 3 cohort only: Has a chronological age from birth up to 1 year and is entering their first RSV season at the time of obtaining documented informed consent.
Is a healthy male or female who is an early or moderate pre-term infant (≥29 to 34 weeks and 6 days gestational age) or a late pre-term or full-term infant (≥35 weeks gestational age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 (postdose) to day 180
Awards & highlights
Study Summary
This trial is testing if clesrovimab, a drug that helps prevent respiratory syncytial virus (RSV), is safe and effective in healthy infants.
Who is the study for?
This trial is for healthy pre-term and full-term infants up to 1 year old, entering their first RSV season. It includes early or moderate pre-term infants (≥29 weeks) and excludes those with hypersensitivity to clesrovimab, bleeding disorders, recent high fever, prior RSV vaccines or treatments, or involvement in other drug/device trials.Check my eligibility
What is being tested?
The study tests the effectiveness of Clesrovimab against a placebo in preventing medically attended lower respiratory infections caused by RSV in infants. This phase 2b/3 trial randomly assigns participants to receive either the medication or a placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the injection site, allergic responses due to sensitivity to clesrovimab's components, and general side effects typically monitored in infant clinical trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is under 1 year old and facing their first RSV season.
Select...
I am a healthy infant born between 29 weeks and full-term.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 (postdose) to day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (postdose) to day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)
Percentage of participants with fever
Percentage of participants with rash AESI
+4 moreSecondary outcome measures
Percentage of participants with RSV-associated MALRI
Percentage of participants with RSV-associated hospitalization
Side effects data
From 2020 Phase 2 trial • 80 Patients • NCT0408647238%
Headache
19%
Upper respiratory tract infection
6%
Abdominal discomfort
6%
COVID-19
6%
Catheter site bruise
6%
Haemorrhoids
6%
Epistaxis
6%
Oropharyngeal pain
6%
Rash
6%
Constipation
6%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-1654 200 mg
MK-1654 100 mg
MK-1654 300 mg
MK-1654 900 mg
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClesrovimabExperimental Treatment1 Intervention
Participants receive a single intramuscular (IM) administration of clesrovimab on Day 1.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive a single IM administration of placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clesrovimab
2019
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,522 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,051,271 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,060,180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only participants who weigh at least 2 kilograms and live in South Korea are eligible.I have a bleeding disorder that prevents me from getting shots in my muscles.I have had a fever of 100.5°F or higher in the last 3 days.My child is under 1 year old and facing their first RSV season.I am advised to get palivizumab as per health guidelines.My child is between 2 weeks and 1 year old and facing their first RSV season.I have received a vaccine or antibody for RSV prevention.I am a healthy infant born between 29 weeks and full-term.You have previously participated in a medical study where you received an experimental drug or device.
Research Study Groups:
This trial has the following groups:- Group 1: Clesrovimab
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT04767373 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different research sites in different states for this project?
"There are 57 sites running this trial, such as BC Women s Hospital and Health Centre ( Site 0506) in Vancouver, Hamilton Medical Research Group ( Site 0509) in Hamilton, and Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics ( Site 0093) in Winston-Salem."
Answered by AI
What is the sample size of this clinical trial?
"In order to run this clinical trial smoothly, 3300 participants who meet the specified inclusion criteria are needed. These participants can come from different sites, such as BC Women s Hospital and Health Centre ( Site 0506) in Vancouver, British Columbia and Hamilton Medical Research Group ( Site 0509) in Hamilton, Ontario."
Answered by AI
Are people still able to sign up to participate in this research?
"That is correct, according to the information available on clinicaltrials.gov this study is still recruiting patients. This trial was originally posted on April 7th, 2021 and was last updated on November 3rd, 2022. The study is looking for 3300 people to participate and has 57 sites enrolling patients."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
District of Columbia
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Holston Medical Group ( Site 0040)
Why did patients apply to this trial?
I would like to help research find solutions to help people with RSV. Here to other making sure the results for testing benefits safety for all.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long is the trial ?
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger