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Clesrovimab for Respiratory Syncytial Virus
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.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 80 Patients • NCT04086472Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Clesrovimab
- Group 2: Palivizumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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