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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2020-001760-29
    Sponsor's Protocol Code Number:ALCOVID-19
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001760-29
    A.3Full title of the trial
    Phase II clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19.
    Ensayo clínico fase II para evaluar la eficacia y seguridad de etanol inhalado en el tratamiento de la COVID-19 en estadio inicial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19.
    Ensayo clínico fase III para evaluar la eficacia y seguridad de etanol inhalado en el tratamiento de la COVID-19 en estadio inicial.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberALCOVID-19
    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 SponsorSociedad Española de Farmacia Hospitalaria
    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 supportSociedad Española de Farmacia Hospitalaria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationC.R.O. Delos Clinical
    B.5.2Functional name of contact pointAlejandro Guerra Hidalgo
    B.5.3 Address:
    B.5.3.1Street AddressCalle Editor José Manuel Lara, número 28, piso 1, puerta B
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.4Telephone number+34630157890
    B.5.5Fax number954308312
    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 nameFórmula magistral de etanol 65º
    D.3.4Pharmaceutical form Nebulisation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEthanol
    D.3.9.1CAS number 64-17-5
    D.3.9.2Current sponsor codeEthanol
    D.3.9.3Other descriptive nameETHANOL
    D.3.9.4EV Substance CodeSUB13730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number65
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Respiratory infection by new coronavirus
    Infección respiratorio por nuevo coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 progression to more serious stages defined by pneumonia, respiratory distress, sepsis, septic shock or death at 14 days and 28 days of follow-up (according to the Spanish Ministry of Health classification of disease severity)
    Evaluar la progresión a estadios de mayor gravedad definidos por neumonía, distrés respiratorio, sepsis, shock séptico o fallecimiento a los 14 días y 28 días de seguimiento (según la clasificación de gravedad de la enfermedad del Ministerio de Sanidad de España)
    E.2.2Secondary objectives of the trial
    1. Evaluate the evolution of hypoxemia using the SaO2 / FiO2 index with respect to the nadir at 1, 2 and 4 weeks.

    2. To evaluate the evolution of the viral load of the patients in the nasopharyngeal sample during the treatment period and subsequent follow-up.

    3. Evaluate the number of patients who normalize body temperature, defined as axillary temperature <37.5 °, without antipyretic treatment for at least 48 hours on the 5th day of treatment.

    4. Evaluate the safety of administering the experimental treatment.
    1. Evaluar la evolución de la hipoxemia mediante el índice SaO2/FiO2 respecto al nadir a las 1, 2 y 4 semanas.

    2. Evaluar la evolución de la carga viral de los pacientes en muestra nasofaríngea durante el periodo de tratamiento y seguimiento posterior.

    3. Evaluar el número de pacientes que normalizan la temperatura corporal, definida como temperatura axilar < 37’5º, sin tratamiento antipirético durante al menos 48 horas al 5º día de tratamiento.

    4. Evaluar la seguridad de la administración del tratamiento experimental.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Institutionalized men or women aged 65 or over at the time of signing the informed consent.
    2. Patients capable of understanding the trial procedures and accepting their participation.

    3. Diagnosis of COVID-19 confirmed by RT-PCR.

    4. Initial stage of the disease diagnosed by:
    - Less than 7 days from the appearance of the first symptoms.
    - Absence of dyspnea
    - Absence of pneumonia
    - SO2> 93% or pO2> 70
    - FR <25 rpm

    5. Signature and date of informed consent before any study-related activity, including evaluations necessary for selection.
    1. Hombres o mujeres institucionalizados de edad igual o mayor a 65 años en el momento de firma del consentimiento informado.
    2. Pacientes capaces de entender los procedimientos del ensayo y aceptar su participación.

    3. Diagnóstico de COVID-19 confirmado por RT-PCR.

    4. Estadio inicial de la enfermedad diagnosticado por:
    - Menos de 7 días desde la aparición de los primeros síntomas.
    - Ausencia de disnea
    - Ausencia de neumonía
    - SO2 > 93% o pO2 > 70
    - FR < 25 rpm

    5. Firma y fecha del consentimiento informado antes de cualquier actividad relacionada con el estudio, incluidas las evaluaciones necesarias para la selección.
    E.4Principal exclusion criteria
    1. Impaired kidney function (creatinine> 2.5 times the normal limit), need for haemofiltration or impaired liver function (ALT or AST> 3 times the normal limits) or diagnosis of severe kidney failure.

    2. Hypersensitivity, allergy or contraindications to the study treatments.

    3. Inability to administer oxygen therapy using Ventimask®.

    4. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.

    5. Consumption of any other drug that could disable him in the judgment of the investigator to participate in the study.

    6. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.

    7. Participation in another clinical study where they received an investigational drug in the 24 weeks prior to signing the informed consent.

    8. Patients diagnosed with chronic bronchopneumopathy.

    9. Patients with a history of epilepsy.

    10. Patients with a history of alcoholism.

    11. Treatment with anticonvulsant drugs used for the treatment of epilepsy and with a higher degree of interaction with ethanol: topiramate, carbamazepine, perampanel and stiripentol

    12. Treatment with drugs that administered concomitantly with ethanol can cause the so-called “disulfiran-like effect”: disulfiran, metronidazole, tinidazole, chloramphenicol, levamisole, nitrofurantoin, isoniazid and griseofulvin.
    1. Función renal alterada (creatinina > 2,5 veces el límite normal), necesidad de hemofiltración o función hepática alterada (ALT o AST > 3 veces los límites normales) o diagnóstico de insuficiencia renal severa.

    2. Hipersensibilidad, alergia o contraindicaciones a los tratamientos del estudio.

    3. Incapacidad de administración de oxigenoterapia utilizando Ventimask®.

    4. Diagnóstico de cualquier otra patología que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.

    5. Consumo de cualquier otra droga que pudiera incapacitarlo a juicio del investigador para participar en el estudio.

    6. Otras circunstancias o dificultades que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.

    7. Participación en otro estudio clínico donde hayan recibido un fármaco en investigación en las 24 semanas anteriores a la firma del consentimiento informado.

    8. Pacientes diagnosticados de bronconeumopatía crónica.

    9. Pacientes con antecedentes de epilepsia.

    10. Pacientes con antecedentes de alcoholismo.

    11. Tratamiento con fármacos anticonvulsivantes utilizados para el tratamiento de la epilepsia y que presenten un grado de interacción mayor con el etanol: topiramato, carbamazepina, perampanel y stiripentol

    12. Tratamiento con fármacos que administrados concomitantemente con el etanol puedan originar el denominado “efecto disulfiran-like”: disulfiran, metronidazol, tinidazol, cloranfenicol, levamisol, nitrofurantoína, isoniazida y griseofulvina.
    E.5 End points
    E.5.1Primary end point(s)
    Progression data: date and symptoms of progression
    Datos de progresión: fecha y síntomas de progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 0, +13 and +27
    Días 0, +13 y +27
    E.5.2Secondary end point(s)
    - Admission data: date and symptoms on admission on day 0.
    - Viral load by real-time quantitative RT-PCR in oropharyngeal sample on days 0, +4, +9, +13, +20 and +27.
    - Need for hospital admission and its duration
    - Death: date and cause on the end of study day.
    - Risk factors: presence of advanced age, cancer, cardiovascular disease, hypertension, diabetes, COPD, bronchial asthma, obesity and chronic treatments on day 0.
    - Blood oxygen level: arterial oxygen saturation (SaO2) measured first thing in the morning, and inspiratory fraction of oxygen (FiO2) on days 0, +4, +9, +13, +20 and +27.
    - Body temperature: axillary temperature on days 0, + 1, + 2, +4.
    - Antipyretic treatment on day 0, +1, +2 and +4.
    - Basic analytics on days 0, +4
    - Analytical determination ethanol day +4
    - ECG abnormalities
    - Symptoms of bronchospasm after administration of each inhalation.
    - Adverse events on days 0 to +27.
    - Datos del ingreso: fecha y síntomas al ingreso en el día 0.
    - Carga viral mediante RT-PCR cuantitativa en tiempo real en muestra orofaríngea en los días 0, +4, +9, +13, +20 y +27.
    - Necesidad de ingreso hospitalario y duración del mismo
    - Fallecimiento: fecha y causa en el día fin de estudio.
    - Factores de riesgo: presencia de edad avanzada, cáncer, enfermedad cardiovascular, hipertensión, diabetes, EPOC, asma bronquial, obesidad y tratamientos crónicos en el día 0.
    - Nivel de oxígeno en sangre: saturación arterial de oxígeno (SaO2) medida a primera hora de la mañana, y fracción inspiratoria de oxígeno (FiO2) en los días 0, +4, +9, +13, +20 y +27.
    - Temperatura corporal: temperatura axilar en los días 0, +1,+2, +4.
    - Tratamiento antipirético en el día 0, +1, +2 y +4.
    - Analítica básica en los días 0, +4
    - Analítica determinación etanol día +4
    - Alteraciones ECG
    - Sintomas de broncoespasmo tras administración de cada inhalación.
    - Acontecimientos adversos en los días 0 a +27.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 0, +1, +2, +4, +9, +13, +20 y +27.
    Días 0, +1, +2, +4, +9, +13, +20 y +27.
    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. 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 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 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 concerned2
    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
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 156
    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 state156
    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)
    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 Decision2020-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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