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    Summary
    EudraCT Number:2020-001870-32
    Sponsor's Protocol Code Number:CDFV890D12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001870-32
    A.3Full title of the trial
    Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
    Estudio de fase 2, multicéntrico, aleatorizado, controlado y abierto para evaluar la eficacia y seguridad de DFV890 para el tratamiento en pacientes infectados por SARS-CoV-2 con neumonía y deterioro de la función respiratoria por COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess efficacy and safety of DFV890 in patients with COVID-19 pneumonia and impaired respiratory function
    Estudio de la eficacia y la seguridad de DV890 en pacientes con neumonía por COVID-19.
    A.4.1Sponsor's protocol code numberCDFV890D12201
    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 SponsorNovartis Farmacéutica S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34900353036
    B.5.5Fax number34932479903
    B.5.6E-maileecc.novartis@novartis.com
    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 No
    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 nameDFV890
    D.3.2Product code DFV890
    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 INNNot yet established
    D.3.9.2Current sponsor codeDFV890
    D.3.9.3Other descriptive nameIFM-2427
    D.3.9.4EV Substance CodeSUB208521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 pneumonia and impaired respiratory function
    Neumonía y deterioro de la función respiratoria por COVID-19.
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    Neumonía COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061986
    E.1.2Term SARS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score
    El objetivo principal del estudio es evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en la puntuación de Acute Physiology and Chronic Health Evaluation II (APACHE II).
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status
    • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status
    • To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone
    - Evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en el estado inflamatorio.
    - Evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en el estado clínico.
    - Evaluar la seguridad de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinically diagnosed with the SARS-CoV-2 virus
    • Hospitalized with COVID-19-induced pneumonia
    • Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg)
    • APACHE II score of ≥10 at time of randomization
    • C-reactive protein (CRP) ≥20 mg/L and/or ferritin level ≥600 μg/L
    • Body weight mass index of ≥18 to <40kg/m2
    - Presentar diagnóstico clínico de virus SARS-CoV-2
    - Estar hospitalizado con neumonía inducida por COVID-19
    - Deterioro de la función respiratoria, definido como saturación periférica de oxígeno (SpO2) =/<93 % respirando aire ambiente o presión parcial de oxígeno (PaO2)/fracción de oxígeno inspirado (FiO2) <300 milímetros de mercurio (mmHg) en la selección
    - Puntuación de APACHE II =/>10 en la selección.
    - Proteína C reactiva (PCR) =/>20 mg/l y/o nivel de ferritina =/>600 μg/l en la selección.
    - Índice de masa corporal de un valor entre =/>18 y <40 kg/m2 en la selección.
    E.4Principal exclusion criteria
    • Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
    • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
    • Intubated prior to randomization
    • Have received either oral anti-rejection, or immunomodulatory drugs within the past 2 weeks, or immunomodulatory therapeutic antibodies within the 5 half-lives or 30 days from randomization (whichever is longer), with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10mg daily or equivalent
    • Treatment with a prohibited drug within 5 half-lives or 30 days (whichever is longer) of randomization or during the course of the study
    •Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline or other evidence of severe hepatic impairment (Child-Pugh Class C)
    • Absolute peripheral blood neutrophil count of ≤1000/mm3
    • Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2
    - Sospecha de infección bacteriana (incluida Mycobacterium tuberculosis), fúngica, vírica u otra infección activa o crónica (además de la infección por SARS-CoV-2).
    - Según el investigador, la progresión a la muerte es inminente e inevitable durante las siguientes 24 horas, independientemente de la administración de tratamiento.
    - Haber estado intubado antes de la aleatorización.
    - Tratamiento previo con fármacos inmunosupresores e inmunomoduladores durante las 2 últimas semanas, o durante los 30 últimos días o 5 vidas medias (aquello que sea más largo) de anticuerpos inmunomoduladores terapéuticos o fármacos prohibidos, con la excepción de hidroxicloroquina, cloroquina o corticosteroides en dosis de hasta 10 mg al día de prednisolona (o equivalente).
    - Alanina transaminasa (ALT) o aspartato transaminasa (AST) en suero >5 veces el límite superior de normalidad detectado durante las 24 horas anteriores a la selección o la basal u otra evidencia en caso de deterioro hepático grave ( clase C de Child-Pugh)
    - Recuento absoluto de neutrófilos en sangre periférica =/<1000/mm3.
    - TFG estimada (TFGe) =/<30 ml/min/1,73m2
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score
    Evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en la puntuación de Acute Physiology and Chronic Health Evaluation II (APACHE II).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15 or on day of discharge (whichever is earlier)
    Día 15 o el día del alta ( lo que sea antes)
    E.5.2Secondary end point(s)
    • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status
    •To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status
    •To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone
    - Evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en el estado inflamatorio.
    - Evaluar el efecto de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia, en el estado clínico.
    - Evaluar la seguridad de DFV890 en combinación con el SoC, comparado con el SoC en monoterapia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to day 29 after first dose
    Hasta el día 29 tras la primera dosis
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    LVLS
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    When the patient is not capable of giving consent, signed informed consent form will be given by his or her legal/authorized representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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
    Ninguno
    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 Decision2020-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-24
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