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

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Overview

  • Trial ID: NCT05986422
    • Link: https://clinicaltrials.gov/study/NCT05986422
    • Sponsor / Lead: Charité University, Berlin, Germany
    • Location(s): Berlin, Germany
    • Phase: Phase 2
    • Status: Recruiting
    • Start Date: 2023-10-01
    • Estimated Completion: 2025-12-31

Purpose of the Trial

This trial is investigating if Methylprednisolone 💊, a well-known immunosuppressant drug, can improve cognitive problems (like memory issues), fatigue, and quality of life in people with Post-COVID-19 Syndrome (PCS). The study is based on the idea that some PCS symptoms may be caused by an autoimmune reaction. The goal is to see if suppressing the immune system with this drug offers a therapeutic benefit for these specific symptoms.

Trial Design & Procedure

  • Duration: 52 weeks.
    • Design: This is a randomized, double-blind, placebo-controlled study. This means participants are randomly assigned to a group, and neither the participants, the investigators, nor the outcome assessors know who is receiving the actual drug versus a placebo (a substance with no active ingredient).
    • Groups: Participants will be split into two groups. One group will receive Methylprednisolone and the other will receive a matching placebo.
    • Procedure: The initial treatment involves taking an oral tablet once daily for six weeks. After the initial six weeks, there is a pause, followed by another six-week period where all participants will receive Methylprednisolone. There are follow-up visits at 8 and 20 weeks, and a final follow-up by phone at 52 weeks.

Key Eligibility Criteria

  • Who may be eligible to participate? (Key Inclusion Criteria) - Adults 18 years or older. - History of a confirmed SARS-CoV-2 infection. - Experiencing ongoing symptoms of PCS for at least 3 months. - Self-reported cognitive difficulties.
    • Who is likely not eligible? (Key Exclusion Criteria)
      • Individuals with other ongoing central nervous system diseases or a major psychiatric disease within the last 10 years.
      • History of gastric ulcer, osteoporosis, rheumatological disease, or diabetes.
      • Currently receiving immunosuppressive therapy.
      • Body weight below 45kg.
      • Individuals who are pregnant or breastfeeding.