NCT04889040终止3 期
A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 216
- 试验地点
- 50
- 主要终点
- Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
研究概览
简要总结
This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the 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
- •Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) ≤72 hours prior to randomization
- •At least three of the following symptoms of at least moderate (score ≥2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea.
- •Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset ≤5 days before dosing on Day 1
排除标准
- •Clinical signs indicative of COVID-19 illness requiring hospitalization
- •Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
- •In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
- •Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization
- •Treatment with a COVID-19 therapeutic agent including, but not limited to, other direct or indirect acting antivirals against SARS-CoV-2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or interleukin 6 (IL-6), intravenous immunoglobulin or other EUA-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
- •Concomitant use of P-glycoprotein inhibitors or inducers listed as prohibited therapy in the protocol
- •Known allergy or hypersensitivity to components of study drug
- •Abnormal laboratory test results at screening
- •Requirement of any prohibited medications during the study
- •Other known active viral or bacterial infection at the time of screening, such as influenza
- •Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
- •COVID-19 vaccination within ≤ 40-days prior to enrollment (second dose if applicable)
研究组 & 干预措施
Placebo
Placebo Comparator
The dose and regimen of the placebo will match that of AT-527.
干预措施: Placebo (Drug)
RO7496998 (AT-527)
Experimental
Orally administered, 550 mg twice daily (BID) for 5 days
干预措施: RO7496998 (Drug)
结局指标
主要结局
Time to Alleviation or Improvement of COVID-19 Symptoms (21.5 Hours)
时间窗: Up to 29 days
COVID-19 symptoms will be evaluated using the COVID-19 Symptom Diary (questions 1-12). The severity of each COVID-19 symptom will be recorded on a Likert scale (i.e none/mild/moderate/severe). The time to alleviation or improvement of COVID-19 symptoms is defined as follows: for new symptoms, it is defined as the length of time taken from randomization to the point at which a Score of 0 or 1 has been maintained for a duration of at least 21.5 hours. For preexisting symptoms, it is defined as the time from randomization to when a patient's symptoms have been maintained or improved (requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale) for a duration of 21.5 hours.
次要结局
- Time to Alleviation of COVID-19 Symptoms (43 Hours)(Up to 29 days)
- Time to Cessation of SARS-CoV-2 Viral Shedding(Up to 14 days)
- Percentage of Participants With Adverse Events (AEs)(Up to Day 33 visit)
- Time to One-Category Improvement of Baseline Presenting COVID-19 Symptoms(Up to 29 days)
- Time to Alleviation or Improvement of COVID-19 Symptoms (43 Hours)(Up to 29 days)
- Time to Alleviation of Individual Symptoms(Up to 29 days)
- Duration of Fever(Up to 29 days)
- Percentage of Participants With Any Post-Treatment Infection(Up to Day 33 visit)
- Change From Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA(Baseline and on Days 3, 5, 7 and 14)
- Plasma Concentration of AT-551 at Specified Timepoints(Up to 7 days)
- Plasma Concentration of AT-273 at Specified Timepoints(Up to 7 days)
- Time to Alleviation of COVID-19 Symptoms (21.5 Hours)(Up to 29 days)
- Percentage of Participants Requiring Hospitalization for COVID-19(Up to Day 33 visit)
- Percentage of Participants Positive for SARS-CoV-2 Virus RNA at Specified Timepoints(Baseline and on Days 3, 5, 7 and 14)
- Area Under the Curve (AUC) in the Amount of SARS-CoV-2 Virus RNA(Day 1 prior to dosing, Day 3, Day 5, Day 7 and Day 14)
- Plasma Concentration of AT-511 at Specified Timepoints(Up to 7 days)
- Plasma Concentration of AT-229 at Specified Timepoints(Up to 7 days)
- Percentage of Participants With Greater Than or Equal to 1 COVID-19 Related Medically Attended Visit(Up to Day 33 visit)
- Percentage of Participants With COVID-19 Related Complications(Up to Day 33 visit)
研究者
研究点 (50)
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