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NCT05986422

Methylprednisolone in Patients with Cognitive Deficits in Post-COVID-19 Syndrome (PCS)

Status unknown Phase 2 Last updated 19 February 2025
What this trial tests

Phase 2 trial testing Methylprednisolone in Post-COVID-19 Syndrome in 418 participants. Status unknown.

Timeline
1 October 2023
Primary endpoint
30 April 2025
31 December 2025

Quick facts

Lead sponsorCharite University, Berlin, Germany
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment418
Start date1 October 2023
Primary completion30 April 2025
Estimated completion31 December 2025
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Post-COVID-19 Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to learn about the therapeutic value of Methylprednisolone, a well-known immunosuppressant, on cognitive deficits in patients with post-COVID-19 syndrome (PCS). The main questions it aims to answer are: 1) Does Methylprednisolone improve memory function in PCS patients compared to placebo? 2) Does Methylprednisolone improve other patient centered outcomes in PCS patients such as fatigue, mood and quality of life compared to placebo? 3)What are the side effects of Methylprednisolone in this patient population, and how common are they? Participants in this study will be patients with PCS and cognitive deficits, who will be asked to participate for 52 weeks. They will be randomly assigned to one of two groups: One group will receive Methylprednisolone once daily for six weeks, with a dosage reduction after week 4. The other group will receive a matching placebo once daily for six weeks, following the same titration regimen to ensure blinding. Participants will attend outpatient follow-up visits in weeks 8 and 20, with a final telephone follow-up after 52 weeks. Clinical examinations and safety monitoring will be conducted during the treatment phase. This study's results may help develop more effective therapies for this condition.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Post-COVID-19 condition: clinical phenotypes, pathophysiological mechanisms, pathology, and management strategies.
    Vlaming-van Eijk LE, Tang G, Bourgonje AR, den Dunnen WFA, et al · · 2025 · cited 5× · PMID 40492581 · DOI 10.1002/path.6443

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Other trials of Methylprednisolone

Trials testing the same drug.

Other recruiting trials for Post-COVID-19 Syndrome

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Other Charite University, Berlin, Germany trials

Trials by the same sponsor.

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