Actively Recruiting
Phase III Study of Oral Deuremidevir Hydrobromide in Treating Respiratory Syncytial Virus Infection in Infants and Young Children
Led by Simcere Pharmaceutical Co., Ltd · Updated on 2026-04-02
498
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of Deurremidevir Hydrobromide oral suspension in infants and young children aged 1 to 36 months who have respiratory syncytial virus RSV infection. This Phase III randomized, double-blind, placebo-controlled trial aims to understand how this investigational drug affects RSV symptoms and disease recovery compared to placebo. The trial is sponsored by Simcere Pharmaceutical Co., Ltd and will enroll about 498 participants. Participants will be randomly assigned in a 21 ratio to receive either Deurremidevir Hydrobromide called SIM0916 or a placebo. The drug dose is adjusted by weight, given at 20 mg per kilogram three times daily for five consecutive days, totaling 15 doses. The study monitors participants through this treatment period, comparing outcomes between the drug and placebo groups. During the study, infants and children will be regularly assessed for RSV-related clinical signs and symptoms, including wheezing and cough, using scores like the Wang Bronchiolitis Score. Researchers will track recovery times and the need for intensive care or respiratory support. Safety and symptom resolution will be followed up to day 26 after the first dose. The total participation duration covers screening, treatment, and follow-up assessments to evaluate the drugs impact and monitor safety.
CONDITIONS
Brief 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 to 36 months, any gender
- Weight between 2.5 kg and 20 kg
- Positive RSV antigen or nucleic acid test
- Illness duration due to RSV infection of 96 hours or less
- Presence of tachypnea (rapid breathing) and wheezing
- Wang Bronchiolitis Score of 5 or higher
- For children under 12 months, head circumference within normal range for age and gender
You will not qualify if you...
- Use of prohibited medications specified by the study protocol
- Severe lung or other organ complications
- Need for vasopressors or inotropic agents
- Known concurrent infections like SARS-CoV-2, influenza, Mycoplasma, bacterial or other pathogens
- History of high carbon dioxide levels (hypercapnia)
- Chronic or persistent feeding difficulties
- Gastrointestinal diseases affecting drug absorption
- Congenital metabolic disorders
- Bronchopulmonary dysplasia requiring assisted ventilation or significant 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
- Primary immune deficiencies or transplant recipients
- History of epilepsy or febrile convulsions
- Personal or family history of severe allergies
- Active or uncontrolled serious diseases of the lungs, heart, liver, brain, kidneys, or others deemed unsuitable by the investigator
- Participation in other clinical trials with investigational drugs or devices
- Other reasons deemed unsuitable by the investigator
Research Team
Z
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