jRCT2031250022招募中不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- MSD K.K.
- 入组人数
- 3,082
- 主要终点
- 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)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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 degrees 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 >=35, diabetes)
- •Is unable 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 renal or hepatic impairment
- •Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
- •Has uncontrolled HIV infection
- •Has known or suspected NMV/r resistance
- •NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)
- •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.
排除标准
- •Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
- •Has received or plans to receive SARS-CoV-2 directed 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
- •Is receiving >4 liters/minute supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2
- •Has received a COVID-19 vaccine within 30 days prior to randomization
- •Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization
- •Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir
结局指标
主要结局
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)
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)
Percentage of Participants Who Experience an Adverse Event (AE)
时间窗: Up to 5 months
Percentage of Participants Who Experience an Adverse Event (AE)
Percentage of Participants Who Discontinue Study Intervention Due to AE
时间窗: Up to 5 days
Percentage of Participants Who Discontinue Study Intervention Due to AE
次要结局
未报告次要终点
研究者
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