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Набор скоро начнётся NCT07746544

Study of Secutrelvir in Participants With COVID-19

Фаза III С лечением COVID-19

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: Secutrelvir, Placebo.
Кому может быть актуально
Состояния в реестре: COVID-19. Базовые параметры: 12 лет — 74 лет · 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
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Secutrelvir in Participants With COVID-19

Обзор

The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.

Вмешательства

  • Препарат Secutrelvir
    Secutrelvir will be administered orally as a tablet.
  • Препарат Placebo
    Placebo will be administered orally as a tablet.

Первичные конечные точки

  • Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Срок оценки: Baseline through Day 21]
Вторичные конечные точки (12)
  • Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28 [Срок оценки: Baseline through Day 28]
  • Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Срок оценки: Baseline through Day 21]
  • Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28 [Срок оценки: Baseline through Day 28]
  • Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Срок оценки: Baseline through Day 21]
  • Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21 [Срок оценки: Baseline through Day 21]
  • Area Under The Curve (AUC) of Change From Baseline in Protocol-defined 14 COVID 19 Symptoms Total Score at Day 8 [Срок оценки: Baseline, Day 8]
  • Time to First Resolution of Fever Based on Body Temperature [Срок оценки: Baseline through Day 28]
  • Time to Sustained Resolution of Fever Based on Body Temperature [Срок оценки: Baseline through Day 28]
  • Change From Baseline in SARS-CoV-2 Viral RNA Level [Срок оценки: Baseline through Day 28]
  • Percentage of Participants With All-cause Hospitalization [Срок оценки: Baseline through Day 21]
  • Percentage of Participants With All-cause Death [Срок оценки: Baseline through Day 21]
  • Plasma Concentration of Secutrelvir and Its Metabolites [Срок оценки: Days 4 and 8]

Критерии участия

Критерии включения

  • Must be 12 to < 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and < 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).
  • Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.
  • Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.
  • Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.
  • Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.

Критерии исключения

  • Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
  • Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.
  • Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
  • Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.
  • Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
  • Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis.
  • Current severely immunocompromised conditions.
  • Received or expected to receive any other COVID-19-specific therapies.
  • Have previously received secutrelvir.
  • Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

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

Япония · 1 центр
  • Japanese Site 1 — Multiple Locations

Идентификаторы

NCT: NCT07746544 · 2512T1631

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗