Prednisolone and Vitamin B1/​6/​12 in Patients With Post-Covid-Syndrome (PreVitaCOV)

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Overview

  • Trial ID: NCT05638633
    • Link: https://clinicaltrials.gov/study/NCT05638633
    • Sponsor / Lead: Wuerzburg University Hospital
    • Location(s): Kiel, Tuebingen, Würzburg, Germany
    • Phase: Phase 3
    • Status: Completed
    • Start Date: 2022-11-11
    • Estimated Completion: 2025-01-30

Purpose of the Trial

This trial investigated the effectiveness of treating Post-COVID-19 Syndrome (PC19S) with the corticosteroid Prednisolone 💊 and a Vitamin B compound 💊 (B1, B6, B12). The study aimed to determine if these treatments, known for their anti-inflammatory and nerve-supporting properties respectively, could alleviate disabling symptoms like fatigue, cognitive issues, and shortness of breath in affected patients. The trial tested the medications both individually and in combination against a placebo.

Trial Design & Procedure

  • Duration: The treatment period for participants was 28 days.
    • Design: This was a randomized, double-blind, placebo-controlled study. This means participants were randomly assigned to a group, and neither the participants, care providers, nor investigators knew who was receiving which treatment.
    • Groups: Participants were split into four groups: one receiving Prednisolone and a placebo for Vitamin B, one receiving Vitamin B and a placebo for Prednisolone, one receiving both active treatments, and one receiving a placebo for both.
    • Procedure: Participants took oral medication daily for 28 days. The Prednisolone group received a higher dose for the first 5 days, followed by a lower dose for the remaining 23 days.

Key Eligibility Criteria

  • Who may be eligible to participate? (Key Inclusion Criteria) - Adults aged 18 years or older. - History of a SARS-CoV-2 infection at least 12 weeks prior. - Persistent symptoms such as fatigue, shortness of breath, or cognitive difficulties that developed during or after the infection.
    • Who is likely not eligible? (Key Exclusion Criteria)
      • Individuals who were treated in an intensive care unit (ICU) for COVID-19.
      • Individuals who are pregnant or breastfeeding.
      • Patients with other severe medical conditions that could explain their symptoms (e.g., chronic heart failure, active cancer, untreated hypothyroidism).
      • Current use of certain medications like immunosuppressive drugs or non-steroidal anti-inflammatory drugs (NSAIDs).