A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection 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 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).

Study Overview

• Status: Recruiting
• Conditions: Respiratory Syncytial Virus Infection
• Intervention / Treatment: Drug: SIM0916; Drug: SIM0916 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 498
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: zhibiao song; Phone Number: 86-13641133681; Email: songzhibiao@simcere.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Yungang Yang; Phone Number: 86-0592-2137303; Email: xmyyg@sina.com
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Children's Hospital
      • Contact: Yanping Chen; Email: hnchengyanping@163.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Second University Hospital Sichuan University
      • Contact: Hanmin Liu; Phone Number: (028) 85503960; Email: Hanmin@vip.163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Shulan(hangzhou)Hospital
      • Contact: lanjuan Li; Phone Number: 86 571 87236456; Email: ljli@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIM0916	Drug: SIM0916; Dose: 20 mg/kg TID
Placebo Comparator: SIM0916 Placebo	Drug: SIM0916 Placebo; Dose: 20 mg/kg TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms	The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms. Resolution of 6 RSV infection-related clinical signs and symptoms is defined as a score of 0 for all of 6 RSV infection-related clinical signs.	Day 26

Secondary Outcome Measures

Outcome Measure	Time Frame
The earliest time from the first dose to the sustained relief/resolution of wheezing.Relief/resolution of wheezing is defined as a wheezing score ≤ 1.	Day 26
Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose	Day 26
Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1	Day 26
Proportion of subjects achieving RSV disease recovery (Wang Bronchiolitis Score ≤ 1 at daily assessment) on each day from Day 2 to Day 6 and on Day 14 after the first dose	Day 26
Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms	Day 26
Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms	Day 26
Proportion of subjects with wheezing score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose;	Day 26
Time from the first dose to the sustained relief/resolution of cough. Relief/resolution of cough is defined as a cough score ≤ 1	Day 26
Proportion of subjects with cough score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose	Day 26
Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases;	Day 26
Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases	Day 26

Other Outcome Measures

Outcome Measure	Time Frame
Change in viral load from baseline on Days 2-6 and Day 14 after the first dose	Day 26
Proportion of subjects with viral load below the Lower Limit of Quantitation (LLOQ) on Days 2-6 and Day 14 after the first dose	Day 26
Area under the viral load-time curve from baseline to Days 2-6 and Day 14 after the first dose	Day 26

Collaborators and Investigators

• Sponsor: Simcere Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: lanjuan Li, Shulan (Hangzhou) Hospital; Principal Investigator: hanmin liu, West China Second University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: SIM0916-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No