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Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome

NCT05638633 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2025-04-01

No results posted yet for this study

Summary

This is a multicenter, randomized, placebo controlled, double-blind phase III trial with four parallel groups studying studying the feasibility of RCT in primary care as well as the effectiveness of treatment with prednisolone and/or vitamin B1/6/12 for PC19S.

Conditions

  • Post-COVID-19 Syndrome

Interventions

DRUG

Prednisolone 20 mg/ 5 mg

Administration of prednisolone 20 mg for 5 days, followed by prednisolone 5 mg for 23 days.

DRUG

Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)

Administration of vitamin B compound for 28 days.

DRUG

Placebo for Vitamin B compound

Administration of placebo for vitamin B compound placebo for 28 days.

DRUG

Placebo for Prednisolon

Administration of placebo for prednisolone 20 mg for 5 days, followed by placebo for prednisolone 5 mg for 23 days.

Sponsors & Collaborators

  • University Hospital Tuebingen

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Ildikó Gágyor, Prof. Dr. · Director of Institute for General Practice Würzburg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05638633 on ClinicalTrials.gov