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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-001041-20
    Sponsor's Protocol Code Number:F001AM0222_1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2022-001041-20
    A.3Full title of the trial
    Prednisolone and vitamin B1, B6, and B12 in patients with Post-COVID-19-Syndrome (PC19S) – a randomized controlled trial in primary care
    Prednisolon und Vitamin B1, B6 und B12 für Patient/innen mit Post-COVID-19-Syndrom (PC19S) – eine randomisierte kontrollierte Studie in der hausärztlichen Versorgung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prednisolone and vitamin B1, B6, and B12 in patients with Post-COVID-19-Syndrome (PC19S) – a randomized controlled trial in primary care
    Prednisolon und Vitamin B1, B6 und B12 für Patient/innen mit Post-COVID-19-Syndrom (PC19S) – eine randomisierte kontrollierte Studie in der hausärztlichen Versorgung
    A.3.2Name or abbreviated title of the trial where available
    PreVitaCOV
    PreVitaCOV
    A.4.1Sponsor's protocol code numberF001AM0222_1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital Wuerzburg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFederal Ministry of Education and Research (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Wuerzburg
    B.5.2Functional name of contact pointDept. of General Practice
    B.5.3 Address:
    B.5.3.1Street AddressJosef-Schneider-Str.2
    B.5.3.2Town/ cityWuerzburg
    B.5.3.3Post code97080
    B.5.3.4CountryGermany
    B.5.6E-mailgagyor_i@ukw.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vitamin B Komplex Forte
    D.2.1.1.2Name of the Marketing Authorisation holderHevert-Arzneimittel GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVitamine B1-B6-B12
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNThiamine nitrate
    D.3.9.1CAS number 532-43-4
    D.3.9.4EV Substance CodeSUB12366MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPyridoxine hydrochloride
    D.3.9.1CAS number 58-56-0
    D.3.9.4EV Substance CodeSUB15062MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCyanocobalamin
    D.3.9.1CAS number 68-19-9
    D.3.9.4EV Substance CodeSUB06837MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number0,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Predni H Tablinen (R) 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderWinthrop Arzneimittel GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrednisolone
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prednisolon STADA (R) 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderSTADAPHARM GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePrednisolone
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 50-24-8
    D.3.9.4EV Substance CodeSUB10018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-COVID-19-Syndrome (PC19S)
    Post-COVID-19-Syndrom (PC19S)
    E.1.1.1Medical condition in easily understood language
    Post-COVID-19-Syndrome (PC19S)
    Post-COVID-19-Syndrom (PC19S)
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effectiveness, safety and feasibility of treating patients with PC19S in primary care with prednisolone and/or vitamin B1, B6, and B12 in a fixed combination. Main objectives are a better understanding of current Post-COVID care, how it is perceived by patients, and to identify approaches to improve care of these patients.
    Bewertung der Wirksamkeit, Sicherheit und Durchführbarkeit der Behandlung von Patienten mit PC19S in der Primärversorgung mit Prednisolon und/oder Vitamin B1, B6 und B12 in einer festen Kombination. Hauptziele sind ein besseres Verständnis der aktuellen Post-COVID-Versorgung, wie sie von Patienten wahrgenommen wird, und die Identifizierung von Ansätzen zur Verbesserung der Versorgung dieser Patienten.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients' perspectives and needs concerning care of Post-COVID.
    Substudy is included within mainstudy. Chapter 11.10
    Perspektiven und Bedarfe in Bezug auf die Gesundheitsversorgung bei Post-COVID
    Die Sub-Studie ist in das Protokoll der Hauptstudie integriert. Siehe Kapitel 11.10
    E.3Principal inclusion criteria
    1. adult patients (at least 18 years old)
    2. history of SARS-CoV-2 infection at least 12 weeks ago; the infection must be documented by ei-ther a positive PCR or Antibody-Test or be confirmed by the patient’s GP
    3. symptoms concerning at least one of the following domains: fatigue, dyspnea, cognition, anxiety, depression
    4. 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’ GP or the local investigator
    E.4Principal exclusion criteria
    • acute Coronavirus disease (COVID-19) at baseline visit (rapid SARS-CoV-2 antigen test)
    • 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 (e.g., chronic fatigue syndrome, depression, active or preceding cancer therapy, severe anemia, sleep apnea syndrome) as assessed by the patients’ GP or the investigator
    • 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 [e.g., Chronic Obstructive Pulmonary Disease (COPD), Asthma)
    -chronic heart failure [New York Heart Association (NYHA) III and IV]
    -neurological disorders
    -untreated hypothyroidism
    -significantly impaired glucuronidation (e.g., Gilbert-Meulengracht, ROTOR, or Crigler-Najjar syndrome)
    -immunodeficiency or a chronically weakened immune system [e.g., ac-quired immunodeficiency syndrome (AIDS), HIV, lymphoma, chemo-radio- therapy, immunosuppressive pathology]
    -mental disorders (e.g. depression, psychosis, dementia)
    -active cancer
    -any other severe medical conditions that preclude participation as deter-mined by responsible physician
    • current use of
    -immunosuppressive drugs
    -non-steroidal antiinflammatory drugs (NSAID), ASS, Indometacin
    -fluoroquinolones
    -anticoagulation: phenprocoumon or other cumarin derivates, direct oral anticoagulants
    -any other drug with a possible interaction that could exhibit clinically relevant inter-actions with the study medication (as described in Fachinformation Prednisolon STADA®, Predni H Tablinen® Zentiva or Fachinformation Vitamin B komplex Hevert). The decision regarding the clinical relevance of the interactions is at the dis-cretion of the principal 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 med-ication 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 inclu-sion of the study
    • 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)
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of pilot studywill be feasibility and acceptance of screening and recruitment in primary care, as assessed by the retention rate at day 28.
    The primary outcome of confirmatory study will be the change of symptom severity as assessed by a specifically tailored Patient Reported Outcomes Measurement Information Sys-tem (PROMIS) total score referring to five symptom domains known to be typical for PC19S (fatigue, dyspnoea, cognition, anxiety, depression) from baseline to day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pilot phase: after months 15-18
    Confirmatory phase: after months 21-24
    E.5.2Secondary end point(s)
    1. Severity of each PC19 symptom (PROMIS total and subscores in the domains included in the total score, MYMOP; PC19S functional status; PC19 symptom list)
    2. Health related quality of life (EQ-5D-5L and visual analogue scale)
    3. Depression (PHQ 8)
    4. Fatigue (Chalder Scale)
    5. Pain (numeric rating scale for pain)
    6. Cognitive function: Alertness, distractibility, divided attention, flexibility and visual scanning (TAP)
    7. Physical exercise (1minute Sit-to-Stand-Test)
    8. Use of on-demand medication and change in concomitant medication (patient diary)
    9. feasibility and acceptance (qualitative interviews with subgroup sample; questionnaire)
    10. physical examination (auscultation of chest lung and heart, orientating neurological examination, check for edema, lymph node status )
    Safety will be assessed by AE and SAE. In addition, number of patients with ongoing/worsening symptoms: symptoms at the same level or worse two months after inclusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pilot phase: after months 15-18
    Confirmatory phase: after months 21-24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study will be reached either after the pilot study if the feasibility is not given or if the data safety monitoring board suggests and the sponsor decides to stop the study prematurely. Otherwise, the study ends when 340 patients have been included and completed the follow up phone call 3 (LVLS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state340
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Continued treatment of patients beyond this period is not foreseen by study site. After end of participation in the trial the patients will be treated by their GP per standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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