An Exploratory, Randomized, Double-Blind Placebo-Controlled Study to Assess the Safety of an Anti-SARS-CoV-2 Monoclonal Antibody and Response to Treatment in Individuals With Long COVID (outSMART-LC)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score
研究概览
简要总结
Persistent viral infection with viral reservoirs and detection of circulating spike protein after the initial acute illness is one potential pathogenic mechanism for Long COVID. This mechanism may be able to be targeted by SARS-CoV-2 monoclonal antibodies (mAbs). This trial will study the safety and efficacy of AER002 to treat individuals with Long COVID in an adult population.
详细描述
The study will enroll approximately 30 participants who meet the World Health Organization (WHO) Long COVID criteria, with Long COVID attributed to a SARS-CoV-2 variant susceptible to AER002. Participants will be enrolled at a single center and randomized 2:1 to receive a SARS-CoV-2 monoclonal antibody (AER002) 1200mg or placebo. Evaluations will take place at baseline and at timepoints up to 1-year post-infusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
AER002
AER002 1200mg administered once by IV
干预措施: AER002 (Drug)
Placebo
Placebo administered once by IV
干预措施: Placebo (Other)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score
时间窗: Day 90
This measure will evaluate whether there is a difference between treatment with AER002 versus placebo in baseline adjusted mean PROMIS-29 Physical Health Summary Score at Day 90 post-infusion. PROMIS-29 is a validated scale assessing physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, and pain. Each domain is scored on a 5-point scale (without any difficulty, with a little difficulty, with some difficulty, with much difficulty, unable to do). A T-score is calculated from each individual domain. A T score of 50 represents the mean for US general adult population, and 10 is the standard deviation. A lower T score indicates worse physical health.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Health Summary Score(Day 30 and Day 180)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Mental Health Summary Score(Day 30 and Day 180)
- Quality of Life (Global Health Score) 100-point Visual-Analogue Scale(Day 90)
- Quality of Life (5-Item EuroQol EQ-5D-5L) Index Value Score(Day 90)
- Duke Activity Status Index (DASI)(Day 90)
- Composite Autonomic Symptom Score-31 (COMPASS-31)(Day 90)
- World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0)(Day 90)
- Patient Global Impression of Change (PGIC) Scale(Day 90)
- Everyday Cognition Form (ECog-39)(Day 90)
- 6 Minute Walking Test (6MWT)(Day 90)
- Active Stand Test(Day 90)
- Neurocognition Index (NCI) Standard Score From the CNS-VS(Day 90)
- C-Reactive Protein (CRP)(Day 90)
- Erythrocyte Sedimentation Rate (ESR)(Day 90)
- D-Dimer(Day 90)
- Fibrinogen(Day 90)
研究者
Michael Peluso, MD
Assistant Professor, Medicine
University of California, San Francisco