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

NCT07402512 | Recruiting Phase 3

• 1 other identifier: SIM0916-301
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 4

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).

Conditions

Respiratory Syncytial Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Other Outcomes (3)

• 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

Study Arms (2)

SIM0916

EXPERIMENTAL

Drug: SIM0916

SIM0916 Placebo

PLACEBO COMPARATOR

Drug: SIM0916 Placebo

Interventions

SIM0916 DRUG

Dose: 20 mg/kg TID

SIM0916

SIM0916 Placebo DRUG

Dose: 20 mg/kg TID

SIM0916 Placebo

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Simcere Pharmaceutical Co., Ltd: lead

Study Sites (4)

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

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• hanmin liu

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

• lanjuan Li

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhibiao song

CONTACT

86-13641133681; songzhibiao@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)