A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-36
SponsorSimcere Pharmaceutical Co., Ltd
About this trial
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).
Eligibility criteria
Qualifiers
Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;
Weight ≥ 2.5 kg and ≤ 20 kg;
Positive RSV antigen or nucleic acid test
Duration of illness due to RSV infection ≤ 96 hours;
Disqualifiers
Subjects with severe intrapulmonary complications or extrapulmonary complications;
Subjects requiring vasopressors or inotropic agents;
Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;
Subjects with a known history of hypercapnia;
Trial design
Treatments tested in this trial
- SIM0916
- SIM0916 Placebo
Treatment groups
498 Participants
are divided into 2 treatment groupsLocations
4The First Affiliated Hospital Of Xiamen University XiamenFujian, China
Hunan Children's Hospital ChangshaHunan, China
West China Second University Hospital Sichuan University ChengduSichuan, China
Shulan(hangzhou)Hospital HangzhouZhejiang, China
Sponsors and collaborators
Simcere Pharmaceutical Co., Ltd
Lead sponsor
Source ClinicalTrials.gov