NCT05152849已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of AXA1125 in Subjects With Fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
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
- 41
- 试验地点
- 1
- 主要终点
- Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)
研究概览
简要总结
This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving muscle function (metabolism) following moderate exercise in subjects with fatigue-Predominant Post-Acute Sequelae of SARS-CoV-2 as well as the safety and tolerability of AXA1125. Subjects will take one dose of AXA1125 or a placebo twice daily for 28 days.
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and provide written informed consent
- •Male and female adults aged > 18 years and less than 65 years
- •Must have had clinically suspected COVID-19 and a positive antibody test or a documented SARS-CoV-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to Screening
- •Must have fatigue-predominant PASC
- •Other than PASC, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions
排除标准
- •Other than PASC, have an explanation for fatigue
- •Other than PASC, a history or presence of an uncontrolled, clinically significant disease
- •Medical history that includes of Non-invasive or invasive ventilatory support for COVID 19, Intensive care unit or other high dependency unit admission for COVID-19, Hospitalization for >1 week for COVID-19 without intubation
研究组 & 干预措施
AXA1125 33.9g
Experimental
33.9 g AXA1125 administered orally BID with or without food
干预措施: AXA1125 (Drug)
Placebo
Placebo Comparator
Matching Placebo administered orally BID with or without food
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)
时间窗: Baseline to 28 days
次要结局
- Change from baseline in PCr recovery rate as assessed by phosphorus magnetic resonance spectroscopy (31P-MRS)(Baseline to 28 days)
- Proportion of subjects with improvement in PCr recovery rate(Baseline to 28 days)
- Proportion of subjects with a decrease in venous serum lactate level from baseline after a 6MWT(Baseline to 28 days)
- Proportion of subjects with an improvement in fatigue score as assessed by CFQ-11 before and after a 6MWT(Baseline to 28 days)
- Change from baseline in serum lactate level after a 6-minute walk test(Baseline to 28 days)
- Proportion of subjects with serum lactate level ≤3 mmol/L after a 6MWT(Baseline to 28 days)
- Change from baseline in distance traveled during a 6MWT(Baseline to 28 days)
- Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11(Baseline to14 days)
- Change from baseline in subjects' fatigue score as assessed by Chalder Fatigue Questionnaire (CFQ)-11 before and after a 6MWT(Baseline to 28 days)
研究者
研究点 (1)
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