Идёт набор NCT06667700

A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)

Фаза III С лечением Coronavirus Disease (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: Molnupiravir, Placebo.
Кому может быть актуально: Состояния в реестре: Coronavirus Disease (COVID-19). Базовые параметры: от 18 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: США, Аргентина, Бразилия, Болгария, Колумбия +19
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, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression

Обзор

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Вмешательства

Препарат Molnupiravir
Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)
Препарат Placebo
Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses)

Первичные конечные точки

Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization, All-cause Mortality, or Covid-19-related Medically-attended Visit (MAV) [Срок оценки: Up to 29 days]
Percentage of Participants Who Experienced an Adverse Event (AE) [Срок оценки: Up to approximately 5 months]
Percentage of Participants Who Discontinued Study Intervention Due to AE [Срок оценки: Up to approximately 5 days]

Вторичные конечные точки (7)

Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms [Срок оценки: Up to 29 days]
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Titer [Срок оценки: Day 1 (baseline) and up to Day 29]
Percentage of Participants with Undetectable SARS-CoV-2 RNA [Срок оценки: Up to 29 days]
Percentage of Participants Who Experienced One or More of Following Through Day 29: All-cause Hospitalization or All-cause Mortality [Срок оценки: Up to 29 days]
Percentage of Participants With Clinically Important Medical Interventions (CIMI) Associated with COVID-19-related MAV or COVID-19-related Hospitalization Through Day 29 [Срок оценки: Up to 29 days]
Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29 [Срок оценки: Up to 29 days]
Time to Sustained Resolution Without Relapse of all 8 (5 prespecified and 3 determined by baseline prevalence) self-reported COVID-19 signs/symptoms through Day 29 [Срок оценки: Up to 29 days]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

Is an individual of any sex/gender, ≥18 years of age
Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever >38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache
Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:

Advanced age of ≥75 years of age
Immunocompromised
Neurocognitive or physical disability
Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes)
Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following:

Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible
Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
Has severe hepatic impairment
Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
Has known or suspected NMV/r resistance
Has uncontrolled HIV infection
NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)
Is unwilling to receive treatment with NMV/r

Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study.

Критерии исключения

The main exclusion criteria include but are not limited to the following:

Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19:

Shortness of breath at rest
Respiratory rate ≥30 breaths per minute
Heart rate ≥125 beats per minute
Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms
New or increasing need for supplemental oxygen: receiving >4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19
Has received a COVID-19 vaccine within 30 days prior to randomization
Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization
Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir

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: Двойное слепое
Основная цель: Лечение