NCT05629962已完成3 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,285
- 试验地点
- 3
- 主要终点
- Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
研究概览
简要总结
The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive SARS-CoV-2 test conducted ≤ 5 days prior to randomization
- •Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening
- •Subject must be high risk, defined below:
- •Age ≥70 years OR
- •Age ≥55 years with one of the following: i) obesity (body mass index [BMI] ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
- •Age 50 to 54 years with two of the following: i) obesity (BMI ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
- •Age ≥18 years with one of the following: i) Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents ii) One of the following immunocompromising conditions or immunosuppressive treatments: receiving chemotherapy for cancer, hematologic malignancy, being within 2 years of a hematopoietic stem cell transplant, receipt of a solid organ transplant and on immunosuppressive therapy, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter, moderate/severe primary immunodeficiency, taking immunosuppressive medications
- •Use of adequate contraception for females of childbearing potential
排除标准
- •Severe or critical COVID-19 illness
- •Admitted to a hospital within 90 days prior to randomization due to COVID-19
- •Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study
- •Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection
- •Requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted.
- •Other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis C virus (HCV) or HIV providing other eligibility criteria are met.
- •Receiving dialysis or have known severe renal impairment
- •History of severe hepatic impairment (Child-Pugh Class C)
- •Known allergy or hypersensitivity to components of study drug
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Bemnifosbuvir (BEM)
Experimental
干预措施: Bemnifosbuvir (BEM) (Drug)
结局指标
主要结局
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause
时间窗: Day 1 through Day 29
次要结局
- Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause(Day 1 through Day 29)
- Percentage of Subjects Who Died Due to Any Cause(Day 1 through Day 29; Day 1 through Day 60)
- Percentage of Subjects With COVID-19-related Complications(Day 1 through Day 29)
- Percentage of Subjects With COVID-19-medically Attended Visits (Hospitalization, Emergency Room (ER) Visit, Urgent Care Visit, Physician's Office Visit, or Telemedicine Visit) or Who Died Due to Any Cause(Day 1 through Day 29; Day 1 through Day 60)
- Percentage of Subjects With COVID-19 Symptom Relapse(Day 1 through Day 29)
- Percentage of Subjects With Viral Load Rebound(Day 1 through Day 29)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT04242446UCB Biopharma SRL505
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT04242498UCB Biopharma SRL509
已完成
3 期
A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)MPS IV ANCT01275066BioMarin Pharmaceutical177
已完成
3 期
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPDChronic Obstructive Pulmonary DiseaseNCT04535986Verona Pharma plc763
已完成
3 期
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)Hepatitis C, ChronicNCT01370642Merck Sharp & Dohme LLC294