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Study on the Safety and Tolerability of Sisunatovir in Infants and Children with RSV Infection

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a common illness in young children known as Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection. RSV is a virus that can cause infections in the lungs and breathing passages, particularly affecting infants and young children. The study is testing a new medicine called sisunatovir, which is given in the form of a hard capsule. The purpose of the study is to learn about the safety and tolerability of sisunatovir in children with RSV.

Participants in the study will be randomly assigned to receive either the study medicine, sisunatovir, or a placebo, which looks like the medicine but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medicine or the placebo. This helps ensure the results are not biased. The study will also measure the levels of sisunatovir in the blood to understand how the body processes the medicine.

The trial will involve multiple visits to the study center, where participants will receive the medicine and undergo various health checks to monitor their response to the treatment. These checks will include looking for any side effects and measuring important health indicators like heart rate and blood pressure. The study aims to gather important information that could help in the development of treatments for RSV in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed through a positive test for Respiratory Syncytial Virus (RSV) and evidence of a lower respiratory tract infection.
Participants are infants and children up to 60 months old, weighing between 2.5 kg and 23 kg.
Step 2
Randomization
Participants are randomly assigned to receive either the study medicine, sisunatovir, or a placebo. This process is double-blind, meaning neither the participants nor the caregivers know which treatment is being administered.
Step 3
Medication administration
The study medicine, sisunatovir, is administered in the form of a hard capsule. The dosage is 50 mg, taken orally.
The frequency and duration of administration are determined by the study protocol, with the aim of evaluating safety and tolerability.
Step 4
Monitoring and assessments
Participants undergo regular monitoring to assess the incidence of any adverse effects, including abnormal laboratory values, ECG parameters, and vital signs.
Blood samples are taken to measure the concentration of sisunatovir in the plasma, particularly from Day 3 onwards.
Step 5
Completion of the study
The study is estimated to conclude by September 2, 2024. Participants will have completed all required assessments and monitoring by this date.

Who can join the trial?

13 criteria

Participants must be between 1 day and 60 months old and weigh between 2.5 kg and 23 kg.
A positive test for **Respiratory Syncytial Virus (RSV)** is required. This test can be an antigen or molecular test and should be done within 48 hours before joining the study. For babies 30 days old or younger, the test can be done within 72 hours.
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There must be signs of **Lower Respiratory Tract Infection (LRTI)**, which can include:
- Breathing faster than normal for their age:
  - Under 2 months old: 60 breaths per minute or more
  - 2 to 12 months old: 50 breaths per minute or more
  - 12 to 60 months old: 40 breaths per minute or more
  - **SpO2** (oxygen level in the blood) less than 95% when breathing room air.
  - check
    Increased effort to breathe, shown by:
    
    Grunting sounds when breathing out
    Nostrils flaring
    Chest retractions (skin pulling in around the ribs or neck when breathing)
    Sounds heard with a stethoscope, such as:
    
    Wheezing (a whistling sound)
    Rhonchi (a rattling sound)
    Rales or crackles (a crackling sound)
    For children older than 30 days, RSV-related symptoms must have been present for 5 days or less before joining the study. For children 30 days old or younger, symptoms must have been present within 7 days before joining the study.

Who cannot join the trial?

9 criteria

Participants who have a known allergy or sensitivity to the study medication or its ingredients.
Individuals who have participated in another clinical trial within the last 30 days.
Patients with a history of severe heart, liver, or kidney disease.
Individuals who are pregnant or breastfeeding.
Participants with a current or recent infection other than RSV.
Patients who have received a live vaccine within the last 4 weeks.
Individuals with a compromised immune system, meaning their body's defense system is weakened.
Participants who are unable to comply with the study procedures or follow-up visits.
Patients with any other condition that the study doctors believe would make participation unsafe or affect the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Sant Joan De Deu Barcelona
Esplugues De Llobregat, Spain
Verified
Hospital Universitario 12 De Octubre
Madrid, Spain

Trial locations

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Investigated drugs

Sisunatovir is a medication being studied for its potential to treat respiratory infections caused by the Respiratory Syncytial Virus (RSV) in young children. The trial aims to understand how safe and tolerable this medication is for children up to 60 months old who have lower respiratory tract infections due to RSV.

Sisunatovir

What is already known about the treatment

Sisunatovir – Sisunatovir is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating Respiratory Syncytial Virus (RSV) infections, particularly in young children. It is in the early stages of research, specifically a Phase 1b trial, which focuses on evaluating its safety and how the body processes the drug. The main therapeutic use of sisunatovir is to treat RSV infections, which affect the lower respiratory tract. At the molecular level, sisunatovir works by inhibiting the replication of the RSV virus, thereby reducing the severity of the infection. It is classified as an antiviral medication.

Investigated diseases

Respiratory Syncytial Virus (RSV) Infection – This is a common respiratory virus that usually causes mild, cold-like symptoms. It can affect people of all ages but is particularly serious in infants and older adults. The virus spreads through droplets when an infected person coughs or sneezes. In severe cases, RSV can lead to lower respiratory tract infections such as bronchiolitis or pneumonia. Symptoms typically include a runny nose, decrease in appetite, coughing, sneezing, fever, and wheezing. The infection usually lasts a week or two, but symptoms can be more severe and prolonged in vulnerable populations.