Post-COVID-19 SyndromePhase 3PreVitaCOVNCT05638633
Prednisolone and Vitamin B1/6/12 in Patients With Post-Covid-Syndrome
A Phase 3 study testing Prednisolone 20 mg/ 5 mg and Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12) in people with Post-COVID-19 Syndrome, run by Wuerzburg University Hospital at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Prednisolone 20 mg/ 5 mg and Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 3 sitesGermany
- Study dates
- 11 Nov 2022to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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 that could exhibit clinically relevant interactions with the study medication (as described in Fachinformation Prednisolon STADA®, Predni H Tablinen® Zentiva or Fachinformation Vitamin B komplex Hevert). The decision on the clinical relevance of the interactions is at the discretion of the clinical investigator.
- systemic treatment with prednisolone for at least 7 days or any parenteral application since the end of the acute phase of COVID-19; treatment with vitamins B1, B6, or B12 in doses equivalent to the dose of the study medi-cation for at least 7 days or any parenteral application since the end of the acute phase of COVID-19; vitamin supplements containing vitamin B1, B6, or B12 should have been ceased at least 4 weeks prior to the inclusion of the study
- known allergies 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)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Unversity Hospital Schleswig-Holstein
Kiel
University Hospital Tuebingen
Tübingen
University Hospital Wuerzburg
Würzburg, Bavaria, 97080
About this study
Official title: Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care
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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Prednisolone 20 mg/ 5 mg, Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12), Placebo for Vitamin B compound, Placebo for Prednisolon
- Keywords
- Prednisolone, Vitamin B1, Vitamin B6, Vitamin B12, PC19S, Fatigue, ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone 20 mg/ 5 mgDrug
Also called N.I.
Administration of prednisolone 20 mg for 5 days, followed by prednisolone 5 mg for 23 days.
Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)Drug
Also called Vitamin B complex forte
Administration of vitamin B compound for 28 days.
Placebo for Vitamin B compoundDrug
Also called N.I.
Administration of placebo for vitamin B compound placebo for 28 days.
Placebo for PrednisolonDrug
Also called N.I.
Administration of placebo for prednisolone 20 mg for 5 days, followed by placebo for prednisolone 5 mg for 23 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo for Vitamin B compound; Drug: Placebo for Prednisolon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 4 weeks
Secondary outcomes (14)
PROMIS total and subscores
Severity of each PC19 symptom domain (patient reported outcome measurement information system (PROMIS))
Measured: 6 months
Measure Yourself Medical Outcome Profile (MYMOP)
Severity of three subjectively chosen PC19 symptoms
Measured: 6 months
Overall assessment of functional status
Severity of PC19 symptom burden
Measured: 6 months
PC19 symptom list
checklist, number of subjectively present symptoms
Measured: 6 months
EQ-5D-5L
Health related quality of life, 5 point rating scale, 0 to 20 points, higher scores indicate worse outcomes
Measured: 6 months
visual analogue scale
Health related quality of life, 0 to 100 points, higher scores indicate a better outcome
Measured: 6 months
PHQ 8
Depression, 4 point rating scale, 0 to 24 points possible, higher scores indicate a worse outcome
Measured: 6 months
Chalder Scale
Fatigue, 4 point rating scale, 0 to 33 points possible, higher values indicate a worse outcome
Measured: 6 months
Numeric rating scale for pain
Pain, 10 point rating scale, higher values indicate a worse outcome
Measured: 6 months
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)
Measured: 4 weeks
Physical exercise
1minute Sit-to-Stand-Test, number of repetitions, BORG Scale, oxygen-saturation
Measured: 6 months
Use of on-demand medication and change in concomitant medication
intake of on-demand medication, daily drug doses
Measured: 6 months
qualitative assessment of acceptance
qualitative interviews with subgroup sample
Measured: 6 months
feasibility/acceptance
exploratory questionnaire, rating scales and grades
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start11 Nov 2022
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Schleswig-Holstein
- Responsible party
- Sponsor
- Investigators
- Ildikó Gágyor, Prof. Dr., Study director, Director of Institute for General Practice Würzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638633
- Sponsor's protocol ID
- F001AM02222_1
- Other IDs
- 2022-001041-20
- Acronym
- PreVitaCOV
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagyor I, Klug A, Schwager A, Gelbrich G, Joos S, Fiessler C, Haeusler KG, Lunden L, Escales C, Dohring J, Kutterer C, Kaussner Y, Maetzler W, Zolk O, Forster C, Kaduszkiewicz H. Low-dose prednisolone and B vitamins for post-COVID-19 syndrome in Germany: the PreVitaCOV randomised clinical trial. EClinicalMedicine. 2026 Oct 24;101:104264. doi: 10.1016/j.eclinm.2026.104264. eCollection 2026 Nov.
PubMed 42964321
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisolone and Vitamin B1, B6, and B12 in Patients With Post-COVID-19-Syndrome (PC19S) - a Randomized Controlled Trial in Primary Care
- ClinicalTrials.gov ID
- NCT05638633
- Acronym / sponsor ID
- PreVitaCOV / F001AM02222_1
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- Prednisolone, Vitamin B1, Vitamin B6, Vitamin B12, PC19S, Fatigue, ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Schleswig-Holstein
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 1st arm (prednisolone and placebo) | Active comparator | Drug: Prednisolone 20 mg/ 5 mg, Drug: Placebo for Vitamin B compoundDay 1-5: prednisolone 20mg 1x1 and placebo 1x1 Day 6-28: prednisolone 5mg 1x1 and placebo 1x1 |
| 2nd arm (placebo and Vitamin B compound) | Active comparator | Drug: Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12), Drug: Placebo for PrednisolonDay 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 |
| 3rd arm (prednisolone and Vitamin B compound) | Active comparator | Drug: Prednisolone 20 mg/ 5 mg, Drug: Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)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 |
| 4rd arm (placebo and placebo) | Placebo comparator | Drug: Placebo for Vitamin B compound, Drug: Placebo for PrednisolonDay 1-5: Placebo 1x1 and placebo 1x1 Day 6-28: placebo 1x1 and placebo 1x1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone 20 mg/ 5 mgAlso: N.I.Administration of prednisolone 20 mg for 5 days, followed by prednisolone 5 mg for 23 days. | Drug | 1st arm (prednisolone and placebo), 3rd arm (prednisolone and Vitamin B compound) |
| Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12)Also: Vitamin B complex forteAdministration of vitamin B compound for 28 days. | Drug | 2nd arm (placebo and Vitamin B compound), 3rd arm (prednisolone and Vitamin B compound) |
| Placebo for Vitamin B compoundAlso: N.I.Administration of placebo for vitamin B compound placebo for 28 days. | Drug | 1st arm (prednisolone and placebo), 4rd arm (placebo and placebo) |
| Placebo for PrednisolonAlso: N.I.Administration of placebo for prednisolone 20 mg for 5 days, followed by placebo for prednisolone 5 mg for 23 days. | Drug | 2nd arm (placebo and Vitamin B compound), 4rd arm (placebo and placebo) |
Primary outcome
Pilot phase: Proportion of participants retained after 28 days
Time frame: 4 weeks
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
Time frame: 4 weeks
change in symptom severity to day 28 as assessed by specifically tailored total score based on the patient reported outcome measurement information system (PROMIS)
14 secondary outcomes
PROMIS total and subscores
Time frame: 6 months
Measure Yourself Medical Outcome Profile (MYMOP)
Time frame: 6 months
Overall assessment of functional status
Time frame: 6 months
PC19 symptom list
Time frame: 6 months
EQ-5D-5L
Time frame: 6 months
visual analogue scale
Time frame: 6 months
PHQ 8
Time frame: 6 months
Chalder Scale
Time frame: 6 months
Numeric rating scale for pain
Time frame: 6 months
Testbatterie zur Aufmerksamkeitsprüfung (TAP)
Time frame: 4 weeks
Physical exercise
Time frame: 6 months
Use of on-demand medication and change in concomitant medication
Time frame: 6 months
qualitative assessment of acceptance
Time frame: 6 months
feasibility/acceptance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 42964321Gagyor I, Klug A, Schwager A, Gelbrich G, Joos S, Fiessler C, Haeusler KG, Lunden L, Escales C, Dohring J, Kutterer C, Kaussner Y, Maetzler W, Zolk O, Forster C, Kaduszkiewicz H. Low-dose prednisolone and B vitamins for post-COVID-19 syndrome in Germany: the PreVitaCOV randomised clinical trial. EClinicalMedicine. 2026 Oct 24;101:104264. doi: 10.1016/j.eclinm.2026.104264. eCollection 2026 Nov.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ildikó Gágyor, Prof. Dr. study director
Director of Institute for General Practice Würzburg University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisolone 20 mg/ 5 mg and Vitamin B compound (100mg B1, 50 mg B6, 500 µg B12) in people with Post-COVID-19 Syndrome, run by Wuerzburg University Hospital at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot phase: Proportion of participants retained after 28 days (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.