A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 584
- 试验地点
- 101
- 主要终点
- Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures
- •Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
- •Or aged ≥ 60 years
- •Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
- •Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
- •Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)
排除标准
- •Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
- •Prior hospitalization for COVID-19
- •Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
- •Requiring oxygen supplementation
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Remdesivir (RDV)
Participants will receive a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
干预措施: RDV (Drug)
Placebo
Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3.
干预措施: Placebo to Match RDV (Drug)
结局指标
主要结局
Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28
时间窗: Randomization up to Day 28
The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
时间窗: First dose date up to last dose date (maximum: 3 days) plus 30 days
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
次要结局
- Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28(Randomization up to Day 28)
- Percentage of Participants Who Died by Day 28(Randomization up to Day 28)
- Percentage of Participants With COVID-19 Related Hospitalization at Day 28(Randomization up to Day 28)
- Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14(Randomization up to Day 14)
- Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14(Randomization up to Day 14)
- Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7(Baseline up to Day 7)
- Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)(First Dose Date up to Day 14)
- Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire(First dose date up to Day 28)
- Percentage of Participants Who Required Oxygen Supplementation by Day 28(Randomization up to Day 28)