Phase 2a, double-blind, randomized, placebo-controlled trial of methylprednisolone versus placebo in patients with cognitive deficits in post-COVID-19 syndrome (PCS) - PoCoVIT
Phase 1
Recruiting
- Conditions
- Post COVID-19 SyndromeTherapeutic area: Not possible to specify
- Registration Number
- CTIS2023-504826-21-00
- Lead Sponsor
- Charite Universitaetsmedizin Berlin KöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 418
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement in memory satisfaction from baseline to week 8 when comparing methyl-prednisolone with placebo in PCS patients;Secondary Objective: Long-term improvement in memory satisfaction from baseline to week 20 and to week 52, Improvement in memory ability, and memory strategy, Improvement in neurocognitive symptoms quantified using neuropsychological and cognitive scores, Improvement in quality of life, Improvement in fatigue and mood;Primary end point(s): to show an intra-patient change in MMQ, subdomain memory satisfaction by =15 points from baseline to week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s):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;Secondary end point(s):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;Secondary end point(s):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;Secondary end point(s):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;Secondary end point(s):Intra-patient change in fatigue scores (FSS, Chandler Fatigue Scale) and mood (BDI) from baseline to week 8