NCT04847544已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of ADX-629 Administered Orally for the Treatment of COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Subjects With Serious Adverse Events
研究概览
简要总结
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of ADX-629 Administered Orally for the Treatment of COVID-19
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Is a male or female greater than or equal to18 years of age at Screening;
- •Is willing and able to sign and date (or has a legally authorized representative willing to sign and date) a written (or electronic) informed consent form or provide equivalent consent per Food and Drug Administration guidelines on COVID-19 clinical trials;
- •Has a documented, laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction, a SARS-CoV-2 antigen test, or another commercial or public health assay, within 3 days (72 hours) of randomization;
- •Has COVID-19 of moderate severity, as defined by the following: Positive testing by standard reverse transcription polymerase chain reaction assay or equivalent testing; Symptoms of illness with COVID-19, which could include any of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, or new loss of taste or smell; Clinical signs suggestive of illness with COVID-19, such as respiratory rate greater than or equal to 20 breaths per minute, saturation of oxygen greater than 93% on room air at sea level, or heart rate greater than or equal to 90 beats per minute; and No clinical signs indicative of severe or critical severity.
排除标准
- •Has an NIAID ordinal scale score <5;
- •Is on high-flow oxygen or any form of noninvasive ventilation, excluding continuous positive airway pressure (CPAP) alone for sleep disorders (e.g., obstructive sleep apnea);
- •Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension (diastolic blood pressure greater than or equal to 100 mmHg or systolic blood pressure greater than or equal to 160 mmHg); history of congenital prolonged QT syndrome, or known dyslipidemia;
- •Is currently taking any investigational products, other than the study drug;
- •Has any other condition that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the clinical trial or interpretation of the clinical trial results or that would place the subject at undue risk by participating in the clinical trial.
研究组 & 干预措施
ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.
Experimental
干预措施: ADX-629 (Drug)
Placebo administered orally BID for up to 28 days.
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Serious Adverse Events
时间窗: The safety assessment period was Days 1 - 28.
Safety was assessed through serious adverse event reporting.
次要结局
- Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale(The efficacy assessment period was 4 weeks; baseline was defined as Day 1 prior to first dose.)
研究者
研究点 (1)
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