A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
研究概览
简要总结
The objectives of this study are to evaluate the safety, tolerability, antiviral activity and efficacy of AT-527 in adult subjects ≥18 years of age with moderate COVID-19 and risk factors for poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma). Eligible subjects will be randomized to blinded AT-527 (nucleotide analog) tablets or matching placebo tablets to be administered orally for 5 days. Part A will evaluate an AT-527 dose of 550 mg BID and Part B will evaluate a second dose of AT-527 (1100 mg BID). Local supportive standard of care (SOC) will be allowed for all subjects. Efficacy, antiviral activity and safety observations will be compared for treatment with active AT-527 tablets vs. placebo tablets.
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)
盲法说明
Blinded
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
- •Hospitalized or in a hospital-affiliated confinement facility
- •SARS-CoV-2 positive
- •Initial COVID-19 symptom onset within 5 days prior to Screening
- •SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
- •Must also have a history of at least one of the following known risk factors for poor outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
排除标准
- •Severe or critical COVID-19 illness: RR ≥30, HR ≥125, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
- •Requires mechanical ventilation
- •Lobar or segmental consolidation on chest imaging.
- •Treatment with other drugs thought to possibly have activity against SARS-CoV-2
- •ALT or AST > 5 x upper limit of normal (ULN)
- •Female subject is pregnant or breastfeeding
- •Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 14 visit (Part B).
研究组 & 干预措施
AT-527 - 550 mg BID
Part A
干预措施: AT-527 (Drug)
Placebo for 550 mg BID
Part A
干预措施: Placebo (Other)
AT-527 - 1100 mg BID
Part B
干预措施: AT-527 (Drug)
Placebo for 1100 mg BID
Part B
干预措施: Placebo (Other)
结局指标
主要结局
Proportions (Active vs. Placebo) of Subjects With Progressive Respiratory Insufficiency (PRI) on or Before Day 14.
时间窗: Day 14
Progressive respiratory insufficiency defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using the 6-tier hierarchical scale of respiratory support methods, within the 14-day study period. Level 1:Normal oxygenation on room air (SpO2 ≥93), no need for supplemental O2 Level 2:Persistent hypoxemia on room air (SpO2 \<93) with requirement for low-level supplemental O2 by nasal cannula/mask (up to 2L/min) to maintain SpO2 ≥93 Level 3:Requirement for higher levels of passive supplemental O2 by nasal cannula or mask (≥2 L/min) to maintain SpO2 ≥93 Level 4:Requirement for oxygenation by positive-pressure devices Level 5:Required invasive respiratory support (intubated mechanical ventilation or ECMO) Level 6:Death
次要结局
- Change From Baseline in Amount of SARS-CoV-2 Virus RNA by Nasopharyngeal Swab(Through Day 14)