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Идёт набор NCT07482657

A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Фаза II С лечением RSV Infection RSV Respiratory Syncytial Virus (RSV)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: zelicapavir, Placebo.
Кому может быть актуально
Состояния в реестре: RSV Infection, RSV, Respiratory Syncytial Virus (RSV). Базовые параметры: 28 Days — 36 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
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Официальное название

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Обзор

Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.

Вмешательства

  • Препарат zelicapavir
    Oral suspension
  • Препарат Placebo
    Placebo oral suspension to match zelicapavir

Первичные конечные точки

  • Time to complete resolution of clinical signs of RSV as measured by RESOLVE-P [Срок оценки: Day 1 through Day 14]
Вторичные конечные точки (10)
  • Time to sustained resolution of clinical signs of RSV as measured by RESOLVE-P [Срок оценки: Day 1 through Day 14]
  • Change in severity of clinical signs of RSV from Baseline to D7 as measured by RESOLVE-P [Срок оценки: Day 1 through Day 7]
  • Proportion of participants with Lower Respiratory Tract Infection (LRTI) [Срок оценки: D1 through D14]
  • Change in severity of RSV from Baseline to D7 and D14 [Срок оценки: Baseline to D7 and D14]
  • Proportion of outpatient participants who were hospitalized due to RSV or other causes during the study period [Срок оценки: Day 1 through Day 35]
  • Change in RSV viral load as measured by RT-qPCR [Срок оценки: Baseline to D7]
  • Proportion of participants with viral load Target Not Detected (TND) [Срок оценки: Day 4, Day 7 and Day 14]
  • Time to viral load TND [Срок оценки: Day 1 through Day 14]
  • Plasma PK Concentrations of zelicapavir [Срок оценки: Up to Day 7]
  • Safety as measured by frequency of adverse events (AEs) [Срок оценки: Up to Day 35]

Критерии участия

Критерии включения

  • Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza
  • Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization
  • In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.

Критерии исключения

  • Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.
  • Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.
  • Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.
  • Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for >5 days.
  • Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Таиланд · 8 центров
  • Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, C — Bangkok
  • Nakornping Hospital — Chiang Mai
  • Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
  • Chiangrai Prachanukroh Hospital — Chiang Rai
  • Khon Kaen Hospital — Khon Kaen
  • Lampang Hospital — Lampang
  • Lamphun Hospital — Lamphun
  • Maha Sarakham Hospital — Maha Sarakham

Идентификаторы

NCT: NCT07482657 · EDP 938-203

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗