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

Primary Purpose

Post-COVID-19 Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Prednisolone 20 mg/ 5 mg
Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)
Placebo for Vitamin B compound
Placebo for Prednisolon
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring Prednisolone, Vitamin B1, Vitamin B6, Vitamin B12, PC19S, Fatigue, ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: adult patients (at least 18 years old) history of documented SARS-CoV-2 infection at least 12 weeks ago symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression Above mentioned symptom(s) that developed during or after the SARS-CoV-2 infection, that persist until study inclusion, and that are associated with COVID 19 as assessed by the patients' general practitioner or the local investigator Exclusion Criteria: 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 hypertension 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 immunodeficiency or a chronically weakened immune system mental disorders active cancer any other severe medical conditions that preclude participation as determined by responsible physician current use of immunosuppressive drugs non-steroidal antiinflammatory drugs (NSAID) fluoroquinolones anticoagulation any other drug with a possible interaction with the study medication current or previous systemic treatment with any of the treatment drugs for at least seven days since COVID-19 or any parenteral application known allergy and contraindications to the intervention drugs need of care and/or peer dependency nursing home residents inability to understand the scope of the study, to follow study procedures and to give informed consent or to attend the study sites participation in another interventional trial at the same time or within the past 3 months before enrolment female patients considering to get pregnant during the first month of the trial and within 1 week after the last dose of study drug(s)

Sites / Locations

  • Unversity Hospital Schleswig-HolsteinRecruiting
  • University Hospital TuebingenRecruiting
  • University Hospital WuerzburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1st arm (prednisolone and placebo)

2nd arm (placebo and Vitamin B compound)

3rd arm (prednisolone and Vitamin B compound)

4rd arm (placebo and placebo)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

PROMIS total and subscores
Severity of each PC19 symptom domain (patient reported outcome measurement information system (PROMIS))
Measure Yourself Medical Outcome Profile (MYMOP)
Severity of three subjectively chosen PC19 symptoms
Overall assessment of functional status
Severity of PC19 symptom burden
PC19 symptom list
checklist, number of subjectively present symptoms
EQ-5D-5L
Health related quality of life, 5 point rating scale, 0 to 20 points, higher scores indicate worse outcomes
visual analogue scale
Health related quality of life, 0 to 100 points, higher scores indicate a better outcome
PHQ 8
Depression, 4 point rating scale, 0 to 24 points possible, higher scores indicate a worse outcome
Chalder Scale
Fatigue, 4 point rating scale, 0 to 33 points possible, higher values indicate a worse outcome
Numeric rating scale for pain
Pain, 10 point rating scale, higher values indicate a worse outcome
Testbatterie zur Aufmerksamkeitsprüfung (TAP)
cognitive function (Alertness: reaction time, distractibility: omissions and reaction time, divided attention: omissions, visual scanning: omissions and reaction time, flexibility: reaction time and errors)
Physical exercise
1minute Sit-to-Stand-Test, number of repetitions, BORG Scale, oxygen-saturation
Use of on-demand medication and change in concomitant medication
intake of on-demand medication, daily drug doses
qualitative assessment of acceptance
qualitative interviews with subgroup sample
feasibility/acceptance
exploratory questionnaire, rating scales and grades

Full Information

First Posted
November 18, 2022
Last Updated
December 1, 2022
Sponsor
Wuerzburg University Hospital
Collaborators
University Hospital Tuebingen, University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT05638633
Brief Title
Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome
Acronym
PreVitaCOV
Official Title
Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
University Hospital Tuebingen, University Hospital Schleswig-Holstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 prove the feasibility of recruitment and retention of patients with PC19S in a primary care setting (pilot study, n=100) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome
Keywords
Prednisolone, Vitamin B1, Vitamin B6, Vitamin B12, PC19S, Fatigue, ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
after Baseline, Randomization to 4 arms: st arm (prednisolone and placebo) nd arm (placebo an Vitamin B compound) rd arm (prednisolone and Vitamin B compound) th arm (placebo and placebo)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
blinded labelling of the study drug by the Hospital pharmacy of the Charité
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1st arm (prednisolone and placebo)
Arm Type
Active Comparator
Arm Description
Day 1-5: prednisolone 20mg 1x1 and placebo 1x1 Day 6-28: prednisolone 5mg 1x1 and placebo 1x1
Arm Title
2nd arm (placebo and Vitamin B compound)
Arm Type
Active Comparator
Arm Description
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
Arm Title
3rd arm (prednisolone and Vitamin B compound)
Arm Type
Active Comparator
Arm Description
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
Arm Title
4rd arm (placebo and placebo)
Arm Type
Placebo Comparator
Arm Description
Day 1-5: Placebo 1x1 and placebo 1x1 Day 6-28: placebo 1x1 and placebo 1x1
Intervention Type
Drug
Intervention Name(s)
Prednisolone 20 mg/ 5 mg
Other Intervention Name(s)
N.I.
Intervention Description
Administration of prednisolone 20 mg for 5 days, followed by prednisolone 5 mg for 23 days.
Intervention Type
Drug
Intervention Name(s)
Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)
Other Intervention Name(s)
Vitamin B complex forte
Intervention Description
Administration of vitamin B compound for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo for Vitamin B compound
Other Intervention Name(s)
N.I.
Intervention Description
Administration of placebo for vitamin B compound placebo for 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo for Prednisolon
Other Intervention Name(s)
N.I.
Intervention Description
Administration of placebo for prednisolone 20 mg for 5 days, followed by placebo for prednisolone 5 mg for 23 days.
Primary Outcome Measure Information:
Title
Pilot phase: Proportion of participants retained after 28 days
Description
feasibility and acceptance of screening and recruitment in primary care; aim > 85 % retention rate of 100 patients enrolled
Time Frame
4 weeks
Title
Confirmatory phase: Mean difference in PROMIS Total Score from day 0 to day 28
Description
change in symptom severity to day 28 as assessed by specifically tailored total score based on the patient reported outcome measurement information system (PROMIS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
PROMIS total and subscores
Description
Severity of each PC19 symptom domain (patient reported outcome measurement information system (PROMIS))
Time Frame
6 months
Title
Measure Yourself Medical Outcome Profile (MYMOP)
Description
Severity of three subjectively chosen PC19 symptoms
Time Frame
6 months
Title
Overall assessment of functional status
Description
Severity of PC19 symptom burden
Time Frame
6 months
Title
PC19 symptom list
Description
checklist, number of subjectively present symptoms
Time Frame
6 months
Title
EQ-5D-5L
Description
Health related quality of life, 5 point rating scale, 0 to 20 points, higher scores indicate worse outcomes
Time Frame
6 months
Title
visual analogue scale
Description
Health related quality of life, 0 to 100 points, higher scores indicate a better outcome
Time Frame
6 months
Title
PHQ 8
Description
Depression, 4 point rating scale, 0 to 24 points possible, higher scores indicate a worse outcome
Time Frame
6 months
Title
Chalder Scale
Description
Fatigue, 4 point rating scale, 0 to 33 points possible, higher values indicate a worse outcome
Time Frame
6 months
Title
Numeric rating scale for pain
Description
Pain, 10 point rating scale, higher values indicate a worse outcome
Time Frame
6 months
Title
Testbatterie zur Aufmerksamkeitsprüfung (TAP)
Description
cognitive function (Alertness: reaction time, distractibility: omissions and reaction time, divided attention: omissions, visual scanning: omissions and reaction time, flexibility: reaction time and errors)
Time Frame
4 weeks
Title
Physical exercise
Description
1minute Sit-to-Stand-Test, number of repetitions, BORG Scale, oxygen-saturation
Time Frame
6 months
Title
Use of on-demand medication and change in concomitant medication
Description
intake of on-demand medication, daily drug doses
Time Frame
6 months
Title
qualitative assessment of acceptance
Description
qualitative interviews with subgroup sample
Time Frame
6 months
Title
feasibility/acceptance
Description
exploratory questionnaire, rating scales and grades
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients (at least 18 years old) history of documented SARS-CoV-2 infection at least 12 weeks ago symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression Above mentioned symptom(s) that developed during or after the SARS-CoV-2 infection, that persist until study inclusion, and that are associated with COVID 19 as assessed by the patients' general practitioner or the local investigator Exclusion Criteria: 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 hypertension 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 immunodeficiency or a chronically weakened immune system mental disorders active cancer any other severe medical conditions that preclude participation as determined by responsible physician current use of immunosuppressive drugs non-steroidal antiinflammatory drugs (NSAID) fluoroquinolones anticoagulation any other drug with a possible interaction with the study medication current or previous systemic treatment with any of the treatment drugs for at least seven days since COVID-19 or any parenteral application known allergy and contraindications to the intervention drugs need of care and/or peer dependency nursing home residents inability to understand the scope of the study, to follow study procedures and to give informed consent or to attend the study sites participation in another interventional trial at the same time or within the past 3 months before enrolment female patients considering to get pregnant during the first month of the trial and within 1 week after the last dose of study drug(s)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Tengelmann
Phone
0931-20130538
Email
Tengelmann_C@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne Kaußner, Dr.
Phone
0931-20147811
Email
Kaussner_Y@ukw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ildikó Gágyor, Prof. Dr.
Organizational Affiliation
Director of Institute for General Practice Würzburg University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Unversity Hospital Schleswig-Holstein
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Kaduszkiewicz, Prof. Dr.
Email
kaduszkiewicz@allgemeinmedizin.uni-kiel.de
Facility Name
University Hospital Tuebingen
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Förster, Dr.
Email
Christian.Foerster@med.uni-tuebingen.de
Facility Name
University Hospital Wuerzburg
City
Würzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Tengelmann
Email
tengelmann_c@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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