2023-507227-36-00招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 753
- 试验地点
- 41
- 主要终点
- Percentage of Participants Who Experienced One or More of following through Day 29: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV)
研究概览
简要总结
- To evaluate the efficacy of MOV compared with placebo as assessed by the percentage of participants in the mITT population who have one or more of the following from randomization through Day 29: hospitalization (all-cause), death (all-cause), or a COVID-19-related MAV.
- To evaluate the safety and tolerability of MOV compared with the placebo in the APaT population.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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°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: 1) advanced age of ≥75 years of age, 2) Immunocompromised, 3) Neurocognitive or physical disability or has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g. diabetes, obesity with body mass index (BMI) ≥ 35, chronic lung diseases)
- •Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following: 1) Is receiving drug(s) highly dependent on cytochrome P450 (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, 2) Is receiving potent CYP3A inducers where significantly reduces nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance, 3) Has severe hepatic impairment, 4) Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use, 5) Has known or suspected NMV/r resistance, 6) Has uncontrolled HIV infection, 7) NMV/r is not approved/authorized in the participant’s country or it is not accessible to participant (e.g. drug shortage), 8) Is unwilling to receive treatment with NMV/r
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 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: 1) shortness of breath at rest, 2) respiratory rate ≥30 breaths per minute, 3) heart rate ≥125 beats per minute, 4) 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, 5) New or increasing need for supplemental oxygen: Receiving >4 liters/min 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 MOV
研究组 & 干预措施
molnupiravir
Experimental
Participants receiving molnupiravir
干预措施: molnupiravir (Drug)
结局指标
主要结局
Percentage of Participants Who Experienced One or More of following through Day 29: 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: Hospitalization, All-cause Mortality, or COVID-19 Related Medically Attended Visit (MAV)
Percentage of Participants Who Experienced an Adverse Event (AE)
Percentage of Participants Who Experienced an Adverse Event (AE)
Percentage of Participants Who Discontinued Study Intervention Due to AE
Percentage of Participants Who Discontinued Study Intervention Due to AE
次要结局
- Time to Sustained Alleviation (without relapse) of all selected 8 (5 prespecified and 3 determined by baseline prevalence), self-reported COVID-19 signs/symptoms
- Change From Baseline in SARS-CoV-2 RNA titer
- Percentage of Participants With Undetectable SARS-CoV-2 RNA
- Percentage of Participants Who Experienced One or More of following through Day 29: All-cause Hospitalization or All-cause Mortality
- Percentage of Participants With Clinically Important Medical Interventions Associated with COVID-19 related MAV or COVID-19 related hospitalization through Day 29
- Time to Sustained Alleviation (without relapse) of all 15 self-reported COVID-19 signs/symptoms through Day 29
- 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
研究者
Dana Byrne
Scientific
Merck Sharp & Dohme LLC
研究点 (41)
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