A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and … (NCT07402512) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
China498 participantsStarted 2026-03-11
Plain-language summary
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).
Who can participate
Age range1 Month – 36 Months
SexALL
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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;
✕
What they're measuring
1
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms