NCT07298005招募中2 期
SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial
Michele van Vugt1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post COVID according to WHO criteria and verified by post COVID physician
- •Post-exertional malaise (PEM) according to DSQ-PEM questionnaire
- •Bell's disability score 20-70%
- •Mild initial SARS-CoV-2 infection (no hospitalisation)
- •WHO performance score of 0 before initial SARS-CoV-2 infection
排除标准
- •Patients at risk for cardiac conduction disorders
- •History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP
- •Clinically significant respiratory or cardiovascular disease
- •Unstable neurological disease
- •Clinically significant active psychiatric disorder that requires treatment
- •History of substance abuse
- •Active malignancy within the past 5 years
- •History of solid organ transplantation
- •Active HIV, hepatitis B or C infection
- •BMI < 18.5 or > 35
- •Pregnancy or breastfeeding
- •Clinically relevant laboratory test value outside the reference range
- •Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs)
- •Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil).
- •Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives
研究组 & 干预措施
Intervention group
Experimental
干预措施: Sonlicromanol (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue
时间窗: Between group differences at week 13
Post-COVID related fatigue measured with the Fatigue Assessment Scale (FAS), a 10-item questionnaire measuring physical/mental fatigue (ranging from 10-50), with scores \<22 indicating no fatigue, 22-34 mild-to-moderate, and ≥35 severe fatigue
Fatigue
时间窗: Between group differences at week 13
Post-COVID related fatigue measured with the Fatigue Assessment Scale
次要结局
- Muscle strength(Between group differences at week 13)
- Cognitive function(Between group differences at week 13)
- Health related quality of life(Between group differences at week 13)
- Muscle strength(Between group differences at week 13)
- Cognitive function(Between group differences at week 13)
- Health related quality of life(Between group differences at week 13)
- Fatigue(Between group differences at week 13)
研究者
Michele van Vugt
Prof. Dr. M. van Vugt
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT07277231BeOne Medicines500
已完成
2 期
A study to test whether BI 706321 combined with ustekinumab helps people with Crohn's DiseaseCrohn`s Disease (CD)2024-512756-38-00Boehringer Ingelheim International GmbH27
招募中
3 期
5% KOH solution vs placebo treatment of actinic keratosis with different treatment durationActinic keratosis2024-514277-21-00INFECTOPHARM Arzneimittel und Consilium GmbH630
招募中
2 期
Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 TrialRecurrence TumorGlioblastomaNCT07263438Centre Hospitalier Universitaire Vaudois59
招募中
1 期
A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obese Patients With Multiple DosesOverweightObesityNCT07280936Beijing Suncadia Pharmaceuticals Co., Ltd124