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

Inclusion criteria

• 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;
• Presence of tachypnea and wheezing;
• Wang Bronchiolitis Score≥ 5;
• For subjects aged < 12 months, head circumference should be within the normal range corresponding to their age and gender.

Exclusion criteria

• Subjects who have received protocol-specified prohibited medications:
• 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;
• Subjects with chronic or persistent feeding difficulties;
• Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;
• Subjects with congenital metabolic abnormalities;
• Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;
• Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;
• Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;
• Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;
• Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;
• Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;
• Subjects with a history of epilepsy or febrile convulsions;
• Subjects with a personal or family history of severe allergies or allergies;
• Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;
• Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;
• Subjects deemed unsuitable for participation in this study by the investigator for any other reason.