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

Official title

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

Overview

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).

Interventions

• Drug SIM0916
  Dose: 20 mg/kg TID
• Drug SIM0916 Placebo
  Dose: 20 mg/kg TID

Primary outcome measures

• The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms [Time frame: Day 26]

Secondary outcome measures (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. [Time frame: Day 26]
• Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose [Time frame: Day 26]
• Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1 [Time frame: 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 [Time frame: Day 26]
• Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms [Time frame: Day 26]
• Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms [Time frame: 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; [Time frame: 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 [Time frame: 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 [Time frame: Day 26]
• Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases; [Time frame: Day 26]
• Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases [Time frame: Day 26]

Eligibility criteria

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;
• 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;
• Subjects with a personal or family history of severe allergies or allergies;
• 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;
• Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;
• Subjects deemed unsuitable for participation in this study by the investigator for any other reason.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 4 centers

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

Identifiers

NCT: NCT07402512 · SIM0916-301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗