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

NCT05638633 | Completed Phase 3 DMC

• 2 other identifiers: F001AM02222_12022-001041-20
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Prednisolone; Vitamin B1; Vitamin B6; Vitamin B12; PC19S; Fatigue; ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)

Outcome Measures

Primary Outcomes (2)

• Pilot phase: Proportion of participants retained after 28 days

  feasibility and acceptance of screening and recruitment in primary care; aim \> 85 % retention rate of 100 patients enrolled

  4 weeks

• Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28

  change in symptom severity to day 28 as assessed by specifically tailored total score based on the patient reported outcome measurement information system (PROMIS)

  4 weeks

Secondary Outcomes (14)

• PROMIS total and subscores

  6 months

• Measure Yourself Medical Outcome Profile (MYMOP)

  6 months

• Overall assessment of functional status

  6 months

• PC19 symptom list

  6 months

• EQ-5D-5L

  6 months

Study Arms (4)

1st arm (prednisolone and placebo)

ACTIVE COMPARATOR

Day 1-5: prednisolone 20mg 1x1 and placebo 1x1 Day 6-28: prednisolone 5mg 1x1 and placebo 1x1

Drug: Prednisolone 20 mg/ 5 mg; Drug: Placebo for Vitamin B compound

2nd arm (placebo and Vitamin B compound)

ACTIVE COMPARATOR

Day 1-5: Placebo 1x1 and Vitamin B compound (100 mg B1, 50 mg B6, 500µ B12) 1x1 Day 6-28: placebo 1x1 and Vitamin B compound (100 mg B1, 50 mg B6, 500 µg B12) 1x1

Drug: Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12); Drug: Placebo for Prednisolon

3rd arm (prednisolone and Vitamin B compound)

ACTIVE COMPARATOR

Day 1-5: prednisolone 20mg 1x1 and Vitamin B compound (100 mg B1, 50 mg B6, 500µg B12) 1x1 Day 6-28: prednisolone 5mg 1x1 and Vitamin B compound (100 mg B1, 50mg B6, 500µg B12) 1x1

Drug: Prednisolone 20 mg/ 5 mg; Drug: Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)

4rd arm (placebo and placebo)

PLACEBO COMPARATOR

Day 1-5: Placebo 1x1 and placebo 1x1 Day 6-28: placebo 1x1 and placebo 1x1

Drug: Placebo for Vitamin B compound; Drug: Placebo for Prednisolon

Interventions

Prednisolone 20 mg/ 5 mg DRUG

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

Also known as: N.I.

1st arm (prednisolone and placebo); 3rd arm (prednisolone and Vitamin B compound)

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

Administration of vitamin B compound for 28 days.

Also known as: Vitamin B complex forte

2nd arm (placebo and Vitamin B compound); 3rd arm (prednisolone and Vitamin B compound)

Placebo for Vitamin B compound DRUG

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

Also known as: N.I.

1st arm (prednisolone and placebo); 4rd arm (placebo and placebo)

Placebo for Prednisolon DRUG

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

Also known as: N.I.

2nd arm (placebo and Vitamin B compound); 4rd arm (placebo and placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (at least 18 years old)
• history of SARS-CoV-2 infection at least 12 weeks ago (the infection must be documented by either a positive PCR or antibody-Test or be confirmed by the patient's GP)
• symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression

You may not qualify if:

• acute Coronavirus disease (COVID-19) at baseline visit
• patients who were treated in the intensive care unit because of COVID-19
• pregnancy/ breastfeeding
• diabetes mellitus
• PC19S symptoms that can be explained by an alternative diagnosis
• History of severe medical conditions such as
• concomitant acute infectious disease
• gastrointestinal ulcer
• liver disease/liver cirrhosis
• malabsorption or condition after bariatric surgery
• chronic airway disease
• chronic heart failure \[New York Heart Association (NYHA) III and IV\]
• neurological disorders
• untreated hypothyroidism
• significantly impaired glucuronidation

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• University Hospital Tuebingen: collaborator
• University Hospital Schleswig-Holstein: collaborator

Study Sites (3)

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Unversity Hospital Schleswig-Holstein

Kiel, Germany

Location

University Hospital Tuebingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue; Fatigue Syndrome, Chronic

Interventions

Prednisolone; Vitamin B 12

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds

Study Officials

• Ildikó Gágyor, Prof. Dr.

  Director of Institute for General Practice Würzburg University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: blinded labelling of the study drug by the Hospital pharmacy of the Charité
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: after Baseline, Randomization to 4 arms: 1. st arm (prednisolone and placebo) 2. nd arm (placebo an Vitamin B compound) 3. rd arm (prednisolone and Vitamin B compound) 4. th arm (placebo and placebo)

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 6, 2022
• Study Start: November 11, 2022
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)