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    Summary
    EudraCT Number:2020-001320-34
    Sponsor's Protocol Code Number:2020-6384
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-15
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001320-34
    A.3Full title of the trial
    A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease - COVID-19
    Een dubbel-blind, placebo-gecontroleerde gerandomiseerde klinische trial met valsartan voor de PReventie van Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease - COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinicial trial to investigate te effect of valsartan compared to placebo on acute respiratory failure in hospitalized SARS-CoV-2-infected patients
    Een klinische studie om het effect te onderzoeken van valsartan, vergeleken met placebo, op acuut respiratoir falen in patiënten die zijn opgenomen met een SARS-CoV-2 infectie.
    A.3.2Name or abbreviated title of the trial where available
    PRAETORIAN-COVID
    A.4.1Sponsor's protocol code number2020-6384
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04335786
    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 SponsorRadboudumc
    B.1.3.4CountryNetherlands
    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 supportNovartis B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportHartstichting
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNetherlands Heart Institute
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointCardiology Research Department
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31621137538
    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 Diovane (Valsartan)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 nameDiovane (Valsartan)
    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 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 number160
    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 Diovane (Valsartan)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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 nameDiovane (Valsartan)
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    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
    SARS-CoV-2 infection
    SARS-CoV-2 infectie
    E.1.1.1Medical condition in easily understood language
    Corona virus infection
    Coronavirus infectie
    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
    To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.
    Het onderzoeken van het effect van de ARB valsartan in vergelijking met placebo op het optreden van IC opname, mechanische beademing of dood.
    E.2.2Secondary objectives of the trial
    • Death within 14 days, 30 days, 90 days and at 1 year, defined as all-cause mortality.
    • Mechanical ventilation and ICU admission within 14 days.
    • Time to ICU admission, mechanical ventilation and death.
    • Occurrence of acute kidney injury within 14 days defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2.
    • Dood binnen 14 dagen, 30 dagen, 90 dagen en na 1 jaar, gedefinieerd als “all-cause-mortality”
    • Mechanische ventilatie en IC opname binnen 14 dagen
    • Tijd tot IC opname, mechanische ventilatie en dood
    • Acute nierschade binnen 14 dagen gedefinieerd als een 50% afname van eGFR ten opzichte van baseline, of een afname van > 30 ml/min/1.73m2 met een waarde <60 ml/min/1.73m2
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    • Age group (above/below median age; above/below 65 years)
    • Gender (male/female)
    • Admission hospital (study site)
    • Hypertension (yes/no)
    • Diabetes (yes/no)
    • Saturation at baseline (above/below median)
    • Treatment with ACE-inhibition (yes/no)
    • Viral load (high/low)
    E.3Principal inclusion criteria
    Adult (age ≥ 18 years)
    • Admitted to the hospital of any participating center
    • Confirmed SARS-CoV-2 infection with either: positive laboratory test for SARS-CoV-2* ; or positive CT thorax diagnostic for SARS-CoV-2 infection according to the prevailing criteria
    • Randomization:
    o Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis
    OR
    o within 24 hours of hospital admission in case of pre-hospital confirmed SARS-CoV-2 infection.
    * In case there is a lack of laboratory tests for SARS-CoV-2 in the participating center of the potentially eligible patient, a positive laboratory test for SARS-CoV-2 will be no longer required. In that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of SARS-CoV-2 infection of that participating center, such as typical abnormalities on pulmonary CT in the setting of high clinical suspicion of SARS-CoV-2 infection.
    Volwassen (leeftijd ≥ 18 years)
    • Opname in een van de participerende centra
    • Bewezen SARS-CoV-2 infectie door ofwel aangetoond positieve laboratoriumtest voor SARS-CoV-2* ; ofwel een positieve CT thorax diagnose voor SARS-CoV-2 infection volgens de op dat moment geldende criteria
    • Randomization:
    o binnen 24 uur vanaf het stellen van de diagnose SARS-CoV-2 infectie in het ziekenhuis
    OF
    o binnen 24 uur vanaf opname in het ziekenhuis in het geval de diagnose SARS-CoV-2 infectie reeds gesteld is voorafgaand aan deze opname.

    * Wanneer er een gebrek aan laboratoriumtesten SARS-CoV-2 is in het participerende centrum van de mogelijk geschikte patiënt, is een positieve test niet langer vereist. In dat geval moet de patiënt voldoen aan de op dat moment geldende criteria voor het stellen van de diagnose binnen dat deelnemende centrum, zoals de aanwezigheid van typische afwijkingen op een long-CT scan in de aanwezigheid van een klinisch hoge verdenking op SARS-CoV-2 infectie.
    E.4Principal exclusion criteria
    • Admitted to ICU prior to randomization
    • Currently taking an ARB or angiotensin-receptor-neprilysin-inhibitor (ARNI)
    • Use of other investigational drugs at the time of enrollment
    • Prior reaction or intolerance to an ARB or ARNI; or severe intolerance to an ACEi, defined as angio-oedema requiring medical intervention
    • Blood pressure less than 105/65 mmHg
    • Potassium greater than 5.5 mEq/L within 4 weeks of study enrollment.
    • Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation
    • A known history of renal artery stenosis
    • AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment. In case of mild to moderate liver dysfunction valsartan dosage will be limited to a maximum of 80mg
    • Severe liver dysfunction, bile cirrhosis or cholestasis
    • Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of valsartan
    • Concurrent treatment with Aliskiren
    • Inability to obtain informed consent
    • Pregnancy or breastfeeding
    • In females of childbearing age, unwillingness to use birth control or to be sexually abstinent for the duration of the study
    • IC-opname voor randomisatie
    • Huidig gebruik van een ARB of een angiotensine-receptor-neprilysine-inhibitor (ARNI)
    • Gebruik van een ander onderzoeksmedicijnn op het moment van deelname
    • Een eerdere reactie op of intolerantie van een ARB of ARNI, of ernstige intolerantie voor ACE-remmers, gedefinieerd als angio-oedeem met de noodzaak tot medische interventie.
    • Bloeddruk die lager is dan 105/65 mmHg
    • Kalium groter dan 5.5 mEq/L in de afgelopen 4 weken
    • Geschatte renale klaring (eGFR) < 30 ml/min/1.73 m2 in de afgelopen 4 weken
    • Voorgeschiedenis van nierarteriestenose.
    • ASAT en/of ALAT >3x groter dan de upper limit of normal in de afgelopen 4 weken. In geval van mild tot matige leverfunctiestoornissen wordt de voor te schrijven valsartan dosering gelimiteerd tot maximaal 80mg
    • Ernstige leverdysfunctie, biliaire cirrose of cholestase
    • Ernstige ondervulling of ernstige acute nierinsufficiëntie die er volgens de onderzoeker voor zorgt dat valsartan niet toegediend kan worden.
    • Huidige behandeling met Aliskiren
    • Het niet mogelijk zijn om informed consent af te nemen.
    • Zwangerschap of het geven van borstvoeding
    • In vruchtbare vrouwen, het niet willen toepassen van anticonceptie danwel seksuele onthouding tijdens de duur van het onderzoek
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the occurrence within 14 days of randomization of either: 1) ICU admission; 2) Mechanical ventilation; 3) Death.
    Het primaire eindpunt is het optreden binnen 14 dagen van randomisatie van of 1) IC opname; 2) mechanische ventilatie; 3) dood.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The occurrence of the main study endpoint will be assessed on a daily basis.
    Het optreden van het primaire eindpunt wordt dagelijks beoordeeld.
    E.5.2Secondary end point(s)
    - All secondary endpoints will be evaluated after the study treatment has ended.
    - death within 30 days, 90 days and 1 year will be evaluated at those timepoints.
    • Dood binnen 14 dagen, 30 dagen, 90 dagen en na 1 jaar wordt beoordeeld op die momenten
    Alle andere eindpunten worden beoordeeld na het staken van de studiebehandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the secondary outcome measures regarding mortality at 30 days, 90 days and 1 year we will use the national database of Central Bureau of Statistics for follow-up.
    For the other secondary outcome measures the follow-up duration will be until the occurrence of the primary endpoint or 14 days after randomization.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 study may be terminated if the study procedures are not being
    performed according to GCP and/or if patients are placed at undue risk
    because of clinically relevant findings.
    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
    E.8.9.2In all countries concerned by the trial months6
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 391
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 651
    F.4.2.2In the whole clinical trial 651
    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)
    None
    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 Decision2020-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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