A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 468
- 试验地点
- 81
- 主要终点
- Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
研究概览
简要总结
The goal of this clinical study is to test how well the study drug, obeldesivir (GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.
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
- 18 Years 至 —（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.
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by PCR or an approved alternative assay (eg. Rapid Antigen Test) ≤ 5 days before randomization. Serologic tests will not be accepted.
- •Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization.
- •Not currently hospitalized or requiring hospitalization.
- •Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease.
排除标准
- •Anticipated use of COVID-19 therapies during the current COVID-19 illness.
- •Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
- •Anticipated need for hospitalization < 48 hours after randomization.
- •New oxygen requirement < 24 hours before randomization.
- •Decompensated cirrhosis (Child-Pugh class B or C) or acute liver injury/failure.
- •Undergoing dialysis, or history of moderate to severe renal impairment.
- •Pregnant or breastfeeding (nursing).
- •Unwilling to use protocol-mandated birth control.
- •Received an approved, authorized or investigational COVID-19 vaccine (including booster dose) <120 days before randomization.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.
干预措施: Obeldesivir Placebo (Drug)
Obeldesivir
Participants will receive obeldesivir 350 mg orally twice daily for 5 days.
干预措施: Obeldesivir (Drug)
结局指标
主要结局
Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization or All-Cause Death by Day 29
时间窗: Up to Day 29
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) were recorded. Percentages were rounded off.
次要结局
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)(First dose date up to 5 Days plus 30 Days)
- Percentage of Participants Experiencing Laboratory Abnormalities(First dose date up to 5 Days plus 30 Days)
- Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation(First dose date up to 5 Days plus 30 Days)
- Percentage of Participants With All-Cause Hospitalization by Day 29(Up to Day 29)
- Percentage of Participants With COVID-19-Related Medically Attended Visits (MAVs) or All-Cause Death by Day 29(Up to Day 29)
- Percentage of Participants With COVID-19-Related MAVs by Day 29(Up to Day 29)
- Percentage of Participants With All-cause Death by Day 29(Up to Day 29)
- Time to COVID-19 Symptom Alleviation by Day 15(Up to Day 15)
- Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5(Day 5)
- Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)(Day 1, 0.75 and 2 hours postdose and Day 5 predose and 0.75 hours postdose)