Actively Recruiting
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
Led by Simcere Pharmaceutical Co., Ltd · Updated on 2026-04-02
498
Participants Needed
4
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection. A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg/kg three times daily for 5 consecutive days (15 doses).
CONDITIONS
Official Title
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants and young children aged 1 month to 36 months, any gender
- Weight between 2.5 kg and 20 kg
- Positive test confirming RSV infection
- Illness duration of 96 hours or less due to RSV
- Presence of rapid breathing and wheezing
- Wang Bronchiolitis Score of 5 or higher
- For children under 12 months, normal head circumference for age and gender
You will not qualify if you...
- Use of prohibited medications specified by the study
- Severe lung or other body complications
- Need for vasopressor or inotropic support
- Known infection with SARS-CoV-2, influenza, Mycoplasma, or suspected bacterial or other infections
- History of high carbon dioxide levels in the blood (hypercapnia)
- Chronic or ongoing feeding difficulties
- Gastrointestinal diseases affecting drug absorption
- Congenital metabolic disorders
- Bronchopulmonary dysplasia needing assisted breathing or major congenital respiratory abnormalities
- Congenital heart disease affecting study evaluation
- Signs of liver failure or abnormal liver tests
- Kidney failure or abnormal kidney tests
- Known or suspected HIV infection
- Known or suspected primary immunodeficiency or transplant recipient
- History of epilepsy or febrile seizures
- Personal or family history of severe allergies
- Active or uncontrolled serious diseases of the lungs, heart, liver, brain, kidneys, or other conditions unsuitable for participation
- Participation in other clinical trials involving investigational drugs or devices
- Any other reasons deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 4 locations
1
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
2
Hunan Children's Hospital
Changsha, Hunan, China
Actively Recruiting
3
West China Second University Hospital Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
4
Shulan(hangzhou)Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
Z
zhibiao song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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