What side effects are associated with this type of intervention?

Monoclonal antibody treatments for Respiratory Syncytial Virus (RSV), such as clesrovimab, commonly cause infusion-related reactions including fever, chills, and rash. Severe reactions like anaphylaxis are rare. There is also an increased risk of infections due to the immunosuppressive effects of these treatments. Clinical trials are crucial to comprehensively determine the safety and side effect profile of new treatments like clesrovimab.

What prior FDA approvals exist?

The FDA has approved several treatments for Respiratory Syncytial Virus (RSV), particularly focusing on monoclonal antibodies. Palivizumab, a monoclonal antibody, has been approved for the prevention of serious RSV disease in high-risk infants and young children. It works by targeting the RSV fusion (F) protein, thereby preventing the virus from entering host cells. Other treatments for RSV primarily include supportive care and antiviral medications like ribavirin, though these are not monoclonal antibodies. Clesrovimab, currently under study, represents a newer approach in the use of monoclonal antibodies to target RSV.

What other types of research exist?

Promising alternatives to Clesrovimab for RSV treatment in 2024 include Nirsevimab, another monoclonal antibody designed to provide passive immunity against RSV, and antiviral drugs like Ribavirin. Additionally, RSV vaccines such as the RSV F protein nanoparticle vaccine are in advanced stages of development and may offer preventive options.

← 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)

Must not have

Has a bleeding disorder contraindicating IM administration

Has had a recent illness with rectal temperature ≥100.5°F (≥38.1°C) or axillary temperature ≥100.0°F (≥37.8°C) within 72 hours predose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 (postdose) to day 180

Summary

This trial is testing a medication called clesrovimab in healthy pre-term and full-term infants. The goal is to see if it can prevent serious lung infections caused by the RSV virus. Clesrovimab works by helping the immune system fight off the virus more effectively.

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.

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.

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 below

Select...

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.

Exclusion Criteria

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

Select...

I have a bleeding disorder that prevents me from getting shots in my muscles.

Select...

I have had a fever of 100.5°F or higher in the last 3 days.

Select...

I have received a vaccine or antibody for RSV prevention.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 (postdose) to day 180 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants with anaphylaxis/hypersensitivity AE of special interest (AESI)

Percentage of participants with fever

Percentage of participants with rash AESI

+4 more

Secondary study objectives

Percentage of participants with RSV-associated MALRI

Percentage of participants with RSV-associated hospitalization

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

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 3

~3900

0 / 5Eligibility 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

The most common treatments for Respiratory Syncytial Virus (RSV) primarily include supportive care, as there are no curative therapies currently available. However, monoclonal antibodies, such as Clesrovimab, are being studied for their potential to reduce the incidence of RSV-associated lower respiratory infections. These antibodies work by targeting specific proteins on the RSV virus, neutralizing its ability to infect host cells and thereby reducing the severity and duration of the infection. Understanding these mechanisms is crucial for RSV patients because it offers a targeted approach to prevent severe respiratory complications, potentially reducing hospitalizations and improving overall outcomes.

New therapies for acute RSV infections: where are we?