Phase III Study of Oral Deuremidevir Hydrobromide in Treating Respiratory Syncytial Virus Infection in Infants and Young Children

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.

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children