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 groupsSponsors and collaborators
Source ClinicalTrials.gov