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

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• The First Affiliated Hospital Of Xiamen University — Xiamen
• Hunan Children's Hospital — Чанша
• West China Second University Hospital Sichuan University — Чэнду
• Shulan(hangzhou)Hospital — Ханчжоу

Идентификаторы

NCT: NCT07402512 · SIM0916-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗