2023-504826-21-00已完成2 期
Phase 2a, double-blind, randomized, placebo-controlled trial of methylprednisolone versus placebo in patients with cognitive deficits in post-COVID-19 syndrome (PCS) - PoCoVIT
Charite Universitaetsmedizin Berlin KöR1 个研究点 分布在 1 个国家目标入组 418 人开始时间: 2023年6月21日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8
研究概览
简要总结
Improvement in memory satisfaction from baseline to week 8 when comparing methyl-prednisolone with placebo in PCS patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •History of confirmed (PCR or serology or rapid antigen detection and sick note or comparable certificate after Dec 21, 2023) SARS-CoV-2 infection according to WHO criteria
- •Ongoing symptoms of PCS for ≥ 3 months
- •Self-reported cognitive deficits at screening
排除标准
- •Any ongoing central nervous system disease
- •Any major psychiatric disease within the last 10 years
- •Previous medical history of gastric ulcer, osteoporosis and/or previous vertebral fractures, rheumatological disease or metabolic disease including diabetes mellitus
- •Ongoing immunosuppressive therapy
- •Patient is pregnant or breastfeeding at screening
结局指标
主要结局
to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8
to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8
次要结局
- Intra-patient change in MMQ subdomain memory satisfaction from baseline to week 20, from week 8 to week 20 and from week 20 to week 52
- Mean difference in MMQ subdomain ‘memory ability’ from baseline to week 8 and to week 20 and from week 8 to week 20 Mean difference in MMQ subdomain ‘memory strategy’ to week 8 and to week 20 and from week 8 to week 20
- Intra-patient change in neuro-psychological and cognitive scores (MoCA, neuropsychological test battery, SDMT) from baseline to week 8 and to week 20 and from week 8 to week 20
- Intra-patient change in quantified PROMIS questionnaire and SF-36 from baseline to week 8 and to week 20 and to week 52 and from week 8 to week 20
- Intra-patient change in fatigue scores (FSS, Chandler Fatigue Scale) and mood (BDI) from baseline to week 8
研究者
Christiana Franke
Scientific
Charite Universitaetsmedizin Berlin KöR
研究点 (1)
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