Clinical Trials Register

Summary
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

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.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-001760-29

A.3

Full 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.3.1

Title 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.3.2

Name or abbreviated title of the trial where available

ALCOVID-19

A.4.1

Sponsor's protocol code number

ALCOVID-19

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sociedad Española de Farmacia Hospitalaria
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sociedad Española de Farmacia Hospitalaria
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	C.R.O. Delos Clinical
B.5.2	Functional name of contact point	Alejandro Guerra Hidalgo
B.5.3	Address:
B.5.3.1	Street Address	Calle Editor José Manuel Lara, número 28, piso 1, puerta B
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34630157890
B.5.5	Fax number	954308312
B.5.6	E-mail	secretaria@delosclinical.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Fórmula magistral de etanol 65º
D.3.4	Pharmaceutical form	Nebulisation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ethanol
D.3.9.1	CAS number	64-17-5
D.3.9.2	Current sponsor code	Ethanol
D.3.9.3	Other descriptive name	ETHANOL
D.3.9.4	EV Substance Code	SUB13730MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	65
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Nebuliser solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

COVID-19

E.1.1.1

Medical condition in easily understood language

Respiratory infection by new coronavirus

Infección respiratorio por nuevo coronavirus

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary end point(s)

Progression data: date and symptoms of progression

Datos de progresión: fecha y síntomas de progresión

E.5.1.1

Timepoint(s) of evaluation of this end point

Days 0, +13 and +27

Días 0, +13 y +27

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

UVUP

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

156

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

156

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-09-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials