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 Nonhospitalized Participants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,011
- 试验地点
- 105
- 主要终点
- Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
研究概览
简要总结
The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.
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)
盲法说明
Participants, personnel directly involved in the conduct of study, and sponsor will not know the treatment participants received.
入排标准
- 年龄范围
- 12 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
- •Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
- •Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.
- •Stuffy or runny nose.
- •Sore throat.
- •Shortness of breath (difficulty breathing).
- •Low energy or tiredness.
- •Muscle or body aches.
- •Headache.
- •Chills or shivering.
- •Feeling hot or feverish.
- •Not currently hospitalized or requiring hospitalization.
排除标准
- •Any risk factors for progression to severe disease.
- •Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-
- •Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
- •Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
- •Received an COVID-19 vaccine (including booster dose) < 120 days before randomization.
- •Self-reported COVID-19 diagnosis < 120 days before randomization.
- •Anticipated need for hospitalization < 48 hours after randomization.
- •New oxygen requirement < 24 hours before randomization.
- •Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
- •Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
- •Undergoing dialysis, or known history of chronic kidney disease.
- •Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
- •Pregnant or breastfeeding.
- •Unwilling to use protocol-mandated contraception.
- •Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
- •Concurrent participation/enrollment in a separate therapeutic clinical study.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Obeldesivir Placebo
Participants will receive obeldesivir placebo twice daily for 5 days.
干预措施: Obeldesivir Placebo (Drug)
Obeldesivir
Participants will receive obeldesivir 350 mg twice daily for 5 days.
干预措施: Obeldesivir (Drug)
结局指标
主要结局
Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
时间窗: First dose date up to Day 29
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: First dose date up to Day 5 plus 30 days
TEAEs were defined as 1 or both of the following: * 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. * Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
Percentage of Participants Experiencing Laboratory Abnormalities
时间窗: First dose date up to Day 5 plus 30 days
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
时间窗: First dose date up to Day 5 plus 30 days
Percentages were rounded off.
次要结局
- Time to COVID-19 Symptom Resolution by Day 29(Day 1 up to 29)
- Percentage of Participants With Moderate Relapse of COVID-19 Symptoms 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 Hospitalization or All-cause Death by Day 29(Up to Day 29)
- Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5(Day 5)
- Time to Antigen Negativity(Day 1 up to Day 29)
- Percentage of Participants With Viral Antigen Rebound(Up to Day 29)
- Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)(Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour)
- Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524(Day 5)
- PK Parameter: Ctau of GS-441524(Day 1 and Day 5)
- PK Parameter: Cmax of GS-441524(Day 1 and Day 5)
- Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29(Up to Day 29)