NCT07402512 A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
| NCT ID | NCT07402512 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Simcere Pharmaceutical Co., Ltd |
| Condition | Respiratory Syncytial Virus Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 498 participants |
| Start Date | 2026-03-11 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 498 participants in total. It began in 2026-03-11 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender; 2. Weight ≥ 2.5 kg and ≤ 20 kg; 3. Positive RSV antigen or nucleic acid test 4. Duration of illness due to RSV infection ≤ 96 hours; 5. Presence of tachypnea and wheezing; 6. Wang Bronchiolitis Score≥ 5; 7. For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender. Exclusion Criteria: 1. Subjects who have received protocol-specified prohibited medications: 2. Subjects with severe intrapulmonary complications or extrapulmonary complications; 3. Subjects requiring vasopressors or inotropic agents; 4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections; 5. Subjects with a known history of hypercapnia; 6. Subjects with chronic or persistent feeding difficulties; 7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug; 8. Subjects with congenital metabolic abnormalities; 9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities; 10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation; 11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests; 12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests; 13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator; 14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients; 15. Subjects with a history of epilepsy or febrile convulsions; 16. Subjects with a personal or family history of severe allergies or allergies; 17. 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; 18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices; 19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.
Contact & Investigator
hanmin liu
PRINCIPAL INVESTIGATOR
West China Second University Hospital
Frequently Asked Questions
Who can join the NCT07402512 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 36 Months, studying Respiratory Syncytial Virus Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07402512 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 498 participants.
Is NCT07402512 currently recruiting?
Yes, NCT07402512 is actively recruiting participants. Contact the research team at songzhibiao@simcere.com for enrollment information.
Where is the NCT07402512 trial being conducted?
This trial is being conducted at Xiamen, China, Changsha, China, Chengdu, China, Hangzhou, China.
Who is sponsoring the NCT07402512 clinical trial?
NCT07402512 is sponsored by Simcere Pharmaceutical Co., Ltd. The principal investigator is hanmin liu at West China Second University Hospital. The trial plans to enroll 498 participants.