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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2020-005020-11
    Sponsor's Protocol Code Number:5000
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-01
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-005020-11
    A.3Full title of the trial
    Randomized multicenter single-blind controlled trial on ozonated blood in COVID-19 severe pneumonia
    Ensayo clínico controlado simple-ciego multicentrico con sangre ozonizada en neumonia grave por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on ozonated blood in COVID-19 severe pneumonia
    Estudio de sangre ozonizada en neumonia grave por COVID-19
    A.4.1Sponsor's protocol code number5000
    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 SponsorPolíclinica Nuestra Señora del Rosario
    B.1.3.4CountrySpain
    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 supportnone
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de Girona
    B.5.2Functional name of contact pointMarc Vives
    B.5.3 Address:
    B.5.3.1Street AddressAv. França, s/n
    B.5.3.2Town/ cityGirona
    B.5.3.3Post code17002
    B.5.3.4CountrySpain
    B.5.6E-mailmvives.girona.ics@gencat.cat
    D. IMP Identification
    D.IMP: 1
    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 AuthorisationSpain
    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 nameOzone
    D.3.2Product code SUB33402
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNozone
    D.3.9.1CAS number 10028-15-6
    D.3.9.3Other descriptive nameOZONE
    D.3.9.4EV Substance CodeSUB33402
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number16
    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) Yes
    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 Yes
    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
    Neumonía COVID-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 pneumonia
    neumonía covid-19
    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 determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 28
    Determinar si la administración de sangre ozonizada se asocia con un aumento de los pacientes que alcanzan la mejoría clínica en el día 28
    E.2.2Secondary objectives of the trial
    To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 14
    To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 7
    To determine whether the use of ozonated blood cause a decrease in time to clinical improvement
    To determine whether the use of ozonated blood cause a decrease in days to obtained a 2-fold decrease in inflammatory markers levels from baseline
    To determine whether the use of ozonated blood cause a decrease in days to improvement of oxygenation index
    To determine whether the use of ozonated blood cause a decrease in days in hospital stay
    To determine whether the use of ozonated blood cause a decrease in in-hospital or 28 days mortality
    Determinar si la administración de sangre ozonizada se asocia con un aumento de los pacientes que alcanzan la mejoría clínica en el día 7
    Determinar si la administración de sangre ozonizada se asocia con un aumento de los pacientes que alcanzan la mejoría clínica en el día 14
    Determinar si la administración de sangre ozonizada se asocia con una disminución de los días hasta mejoría clínica
    Determinar si la administración de sangre ozonizada se asocia con una disminución de los días hasta un descenso de >50% en niveles de marcadores inflamatorios
    Determinar si la administración de sangre ozonizada se asocia con una disminución de los días hasta mejoría del índice de oxigenación
    Determinar si la administración de sangre ozonizada se asocia con un disminución de los días de UCI y hospital
    Determinar si la administración de sangre ozonizada se asocia con una disminución de la mortalidad hospitalaria y a los 28 días
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To determine whether the use of ozonated blood cause an increase rate of clinical improvement at day 28 in patients with high Flow nasal canula or non-invasive mechanical ventilation
    determinar si la administración de sangre ozonizada se asocia con un aumento de los pacientes que alcanzan la mejoría clínica en el día 28 en pacientes con gafas de alto flujo o ventilación mecánica no-invasiva
    E.3Principal inclusion criteria
    1. Men and women over 18 years of age.
    2. Diagnosis of COVID-19 confirmed by positive nasopharyngeal PCR.
    3. Lung infiltrate confirmed by imaging test (chest X-ray or CT) + patient with severe pneumonia (failure of > = 1 organ or SpO2 ambient air of <90% or respiratory rate> = 30) with need for oxygen with nasal canula , Venturi mask, non-rebreathing mask, high-flow nasal goggles or non-invasive mechanical ventilation (NIMV).
    4. Evolution time of <2 weeks from symptom onset to recruitment.
    5. Acceptance to participate in the study and signing of the consent form
    1. Hombres y mujeres mayores de 18 años.
    2. Diagnóstico de COVID-19 confirmado por PCR nasofaringea positiva.
    3. Infiltrado pulmonar confirmada mediante prueba de imagen (Radiografía de tórax o TAC) + paciente con neumonía grave (Fallo de >=1 organo o SpO2 aire ambiente de <90% o frecuencia respiratoria >=30) con necesidad de oxigeno con gafas nasales, mascarilla “Ventimask”, mascarilla con reservorio, gafas nasales de alto flujo o Ventilación mecánica no-invasiva (VMNI).
    4. Tiempo de evolución de < de 2 semanas desde inicio de síntomatología hasta reclutamiento.
    5. Aceptación a participar en el estudio y firma del consentimiento informado.
    E.4Principal exclusion criteria
    1. Patients who have received treatment with systemic ozone six months before admission to the hospital.
    2. Patients who have previously experienced some type of adverse reaction to ozone therapy.
    3. Patients who are aware of having a glucose-6-phosphate-dehydrogenase deficiency
    4. Patients who are not able to clearly understand the objectives and methodology of the study.
    5. Pregnant or lactating patients.
    6. Patients who are intubated with invasive mechanical ventilation.
    7. Patients with decompensated concomitant pathology and / or associated infectious pathology not related to COVID-19.
    1. Pacientes que hayan recibido tratamiento con ozono sistémico seis meses antes de su ingreso en el hospital.
    2. Pacientes que previamente hayan experimentado algún tipo de reacción adversa a la ozonoterapia.
    3. Pacientes conocedores de tener un déficit de Glucosa-6-fosfato-deshidrogenasa
    4. Pacientes que no sean capaces de entender con claridad los objetivos y metodología del estudio.
    5. Pacientes embarazadas o en periodo de lactancia.
    6. Pacientes que están intubados con ventilación mecánica invasiva.
    7. Pacientes con patología concomitante descompensada y/o patología infecciosa asociada no relacionada con COVID-19.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients achieving clinical improvement at day 28
    El porcentaje de pacientes que han alcanzado mejoría clínica en el día 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    -time (days) to clinical improvement or discharge from hospital
    - mortality 28 days after randomization in-hospital mortality.
    -% of patients who have achieved clinical improvement on days 7 and 14
    - number of days alive and free from mechanical ventilation at 28 days
    -% of patients requiring intubation
    - time (days) until a decrease of more than 50% of the levels of ferritin, D-dimer, CRP and LDH, neutrophil-lymphocyte ratio from baseline
    - time (days) until improvement of the oxygenation index with PaO2 / FiO2> 300 mmHg, or SpO2 / FiO2 > 315
    - number of days of ICU stay, hospital stay
    - tiempo (días) hasta mejoría clínica o hasta alta del hospital, cualquiera que se alcance primero
    - mortalidad a los 28 días de la aleatorización mortalidad hospitalaria
    - % de pacientes que han alcanzado mejoría clínica en los días 7 y 14
    - número de días vivos y libres de ventilación mecánica a los 28 días
    - % de pacientes que requieren intubación
    - tiempo (días) hasta disminución de más del 50% de los niveles de ferritina, dimero-D, PCR y LDH, ratio neutrófilos-linfocitos sobre la basal pre-aleatorización
    - tiempo (días) hasta mejoría del índice de oxigenación con PaO2/FiO2 > 300 mmHg, o SpO2/FiO2 > 315
    - número de días de estancia en UCI, estancia hospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    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) 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 Yes
    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
    Grupo 1: Tratamiento estandard + sangre ozonizada. Grupo 2: tratamiento estandard.
    Group 1: Standard treatment + ozonated blood. Group 2: standard treatment.
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    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
    LVSV
    Ultima visita y ultimo paciente
    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 months
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation COVID-19 Networking Group
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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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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