Phase 2a, double-blind, randomized, placebo-controlled trial of methylprednisolone versus placebo in patients with cognitive deficits in post-COVID-19 syndrome (PCS) - PoCoVIT

Conditions

Post COVID-19 Syndrome

Brief summary

to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8

Detailed description

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

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMethylprednisolon 16 mg JENAPHARM®

DRUGP-Tabletten weiß 7 mm Lichtenstein

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
to show an intra-patient change in MMQ, subdomain memory satisfaction by ≥15 points from baseline to week 8	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed