Deuremidevir hydrobromide treatment for RSV in infants and young children

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection

This trial tests whether deuremidevir hydrobromide, given by weight three times daily for five days, helps infants and young children (1–36 months) with confirmed RSV recover faster or have milder symptoms than a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 498 (estimated)
• Ages: 1 Month to 36 Months
• Sex: All
• Sponsor: Simcere Pharmaceutical Co., Ltd (other)
• Locations: 4 sites (Xiamen, Fujian and 3 other locations)
• Trial ID: NCT07402512 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, parallel-group Phase III trial plans to enroll about 498 infants and young children aged 1 to 36 months with confirmed RSV infection and symptom duration ≤96 hours. Participants are randomized 2:1 to receive weight-based deuremidevir hydrobromide (20 mg/kg) or matching placebo three times daily for five consecutive days (15 doses). Eligibility requires tachypnea, wheezing, and a Wang Bronchiolitis Score ≥5, and clinical signs and safety outcomes will be monitored during treatment and follow-up. The trial is being conducted at pediatric hospitals in Xiamen, Changsha, and Chengdu, China.

Who should consider this trial

Good fit: Infants and young children aged 1–36 months, weighing 2.5–20 kg, with a positive RSV test, symptom onset within 96 hours, tachypnea, wheezing, and a Wang Bronchiolitis Score ≥5 are the intended participants.

Not a fit: Children with severe intrapulmonary or extrapulmonary complications, need for vasopressors or inotropes, known concurrent infections (such as SARS-CoV-2, influenza, or Mycoplasma), known hypercapnia, chronic feeding difficulties, or certain gastrointestinal diseases were excluded and are unlikely to benefit in this protocol.

Why it matters

Potential benefit: If successful, the drug could shorten illness duration and reduce symptom severity in infants and young children with RSV.

How similar studies have performed: Other antiviral and monoclonal antibody approaches for RSV have shown mixed but promising results in infants, while deuremidevir is a relatively new candidate with limited late-stage published evidence.

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.

Where this trial is running

Xiamen, Fujian and 3 other locations

• The First Affiliated Hospital Of Xiamen University — Xiamen, Fujian, China (RECRUITING)
• Hunan Children's Hospital — Changsha, Hunan, China (RECRUITING)
• West China Second University Hospital Sichuan University — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Shulan(hangzhou)Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: hanmin liu — West China Second University Hospital
• Study coordinator: zhibiao song

Conditions: Respiratory Syncytial Virus Infection