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    Summary
    EudraCT Number:2020-001431-27
    Sponsor's Protocol Code Number:CovidVal01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-07
    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 number2020-001431-27
    A.3Full title of the trial
    Treatment of Sars-CoV2 infections (Covid-19) in patients without or with chronic kidney disease (CKD) with valsartan vs placebo, a three-armed randomized, partly blinded trial
    Dreiarmige randomisierte, Studie zur Behandlung von Sars-Cov2 Infektionen (Covid-19) bei Patienten ohne oder mit chronischer Niereninsuffizienz mit Valsartan oder Placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is there a benefit in treating novel corona virus (Sars-CoV2) infections with the established antihypertensive valsartan?
    Ist eine Behandlung von Infektionen des neuartigen Coronavirus (Sars-CoV2) mit dem bekannten Blutdruckmedikament Valsartan vorteilhaft?
    A.4.1Sponsor's protocol code numberCovidVal01
    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 SponsorKlinikum St. Georg gGmbH
    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 supportKlinikum St. Georg gGmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum St. Georg gGmbH
    B.5.2Functional name of contact pointGeschäftsführung
    B.5.3 Address:
    B.5.3.1Street AddressDelitzscher Str. 141
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04129
    B.5.3.4CountryGermany
    B.5.4Telephone number004903419090
    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.2.1.2Country 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.3.4Pharmaceutical form 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 INNVALSARTAN
    D.3.9.1CAS number 137862-53-4
    D.3.9.4EV Substance CodeSUB00017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 RoleComparator
    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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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 P- Tabletten Weiß 10mm Lichtenstein Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderLichtenstein
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 placeboTablet
    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
    Sars-Cov2 infection
    Sars-Cov2 Infektion
    E.1.1.1Medical condition in easily understood language
    infection with novel corona Virus (Sars-CoV2)
    Infektion mit neuartigem Coronavirus (Sars-CoV2)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Since there is currently no high level evidence that allows a clear evaluation of advantages or disadvantages of a RAS-system inhibiting therapy (ACE-I, ARB) the influence of RAS-influencing drugs on COVID-19 will be investigated. The randomized switch from ACE-I to ARB against retention of ACE-I will be compared. The new setting with ARB (valsartan) will be compared against the administration of placebo.
    Da es zum aktuellen Zeitpunkt keine klinischen Erkenntnisse mit hoher Evidenz gibt, die eine eindeutige Bewertung über mögliche Vor- oder Nachteile einer das RAS-System hemmenden Therapie (ACE-I, ARB) zulassen, soll die Auswirkung von RAS-beeinflussenden Medikamenten bei COVID-19 geprüft werden. Es soll die Umstellung von ACE-I auf ARB gegen die Beibehaltung von ACE-I randomisiert verglichen werden und die Neueinstellung mit ARB (Valsartan) gegen die Gabe von Placebo verglichen werden.
    E.2.2Secondary objectives of the trial
    By characterizing virus binding epitopes with relevance to a clinically relevant immune response, patient-side protein structures (Ig epitopes) can be identified, which are important for new fast and inexpensive testing possibilities and vaccination development.
    Durch Charakterisierung von Virusbindungsepitopen mit Relevanz zu einer klinisch relevanten Immunantwort lassen sich Patienten-seitige Proteinstrukturen (Ig-Epitope) identifizieren, die für neue schnelle und preiswerte Testmöglichkeiten und Vakzinierungsentwicklung bedeutsam sind
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged over 18 years with given consent, first positive Sars-Cov2 detection within the last three days
    - Patients with pre-existing chronic renal insufficiency in any degree of severity
    - Patients of both gender
    • Patienten über 18 Jahre beiderlei Geschlechts mit gegebener Zustimmungsfähigkeit, erstmaliger positiver Sars-Cov2 Nachweis innerhalb der letzten drei Tage
    • Patienten mit vorbestehender chronischer Niereninsuffizienz jeden Schweregrads
    • Patienten beiderlei Geschlechts entsprechend der vorliegenden Verteilung von Patienten mit positiven Sars-COV2 Nachweis. Damit entspricht die Verteilung des Geschlechts der Studienpatienten der Verteilung in der Population Sars-COV2 positiver Patienten und ist der wissenschaftlichen Fragestellung angemessen.
    E.4Principal exclusion criteria
    - intolerance to RAS-I and ARB
    - Contraindications against ACE/ARB according to current clinical standard
    - History of falls (more than 2 falls in the last 8 weeks)
    - Symptomatic hypotension (i.e. blood pressure < 100 mmHg systolic and/or 50 mmHg diastolic together with hypotensive symptoms)
    - Acute renal failure from stage 2
    - pregnancy
    • Unverträglichkeit gegenüber RAS-I und ARB
    • Kontraindikationen ggü. ACE/ARB gemäss derzeitigen klinischen Standard (schwere Leberfunktionsstörung, biliäre Zirrhose, Gallenwegsverschluss, beidseitiger Nierenarterienstenose, Aortenstenose, Einnahme kontraindizierter Arzneimittel entsprechend Fachinformationen)
    • Sturzanamnese (mehr als 2 Stürze in den letzten 8 Wochen)
    • Symptomatische Hypotonie (d.h. Blutdruck < 100 mmHg systolisch und/oder 50 mmHg diastolisch zusammen mit hypotensiver Symptomatik).
    • Akutes Nierenversagen ab Stadium 2
    • Schwangerschaft
    E.5 End points
    E.5.1Primary end point(s)
    combined clinical improvement (7-category ordinal scale of clinical Status or Hospital discharge)
    kombinierten Besserungsindex (7-kategorialer klinischer Endpunkt oder Entlassung aus dem Krankenhaus)
    E.5.1.1Timepoint(s) of evaluation of this end point
    daily
    täglichj
    E.5.2Secondary end point(s)
    Secondary endpoints are collected post-hoc according to the availability of routine data. Mainly respiratory indices (Horovitz), virus load or PCR results, ventilation frequency, duration of hospitalisation and death are considered.
    Sekundäre Endpunkte werden post-hoc nach Verfügbarkeit von Routinedaten erhoben. Vor allem in Frage kommen respiratorische Indices (Horovitz), Viruslast bzw. PCR-Ergebnisse, Beatmungshäufigkeit, Dauer des stationären Aufenthalts und Tod.
    E.5.2.1Timepoint(s) of evaluation of this end point
    according to availability
    nach Verfügbarkeit
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    teil-verblindet
    partly blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LVLS (last visit = closing lab visit 5 days after Resolution of Covid-19 infection)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-07. Yes
    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 state300
    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)
    Study patients randomly converted from ACE Inhibitors to ARB can remain on that substance in accordance with on-Label medication and Information of their treating physician
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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