NCT05638633

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

Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 321 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PC19S affects a considerable portion of patients after an infection with SARS-CoV-2 with a broad range of disabling symptoms. Neurotropic vitamins such as vitamins B1, B6, an B12, and drugs with anti-inflammatory properties such as corticosteroids were suggested to alleviate symptoms. The trial is designed as a two-step approach that will 1. prove the feasibility of recruitment and retention of patients with PC19S in a primary care setting (pilot study, n=100) 2. investigate the effectiveness and safety of the treatment drugs alone and of their combination (confirmatory study, n= 340). The pilot study will be transformed into a confirmatory study if feasibility is given, defined as retention rate of 85% after enrollment of 100 patients. Or on recommendation of the Data Safety and Monitoring Board (DSMB). In addition, blood samples wil be analysed for routine parameters and vitamin B12 derivates as well as cytokines.

Conditions

• Post-COVID-19 Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-11
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2022-12-06
• Last updated: 2025-04-01

Locations

3 sites across 1 country: Germany