Clinical Trials Register

Summary
EudraCT Number:	2020-001971-33
Sponsor's Protocol Code Number:	CORIVER
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:	2020-07-22
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2020-001971-33

A.3

Full title of the trial

Pragmatic study "CORIVER": Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID-19)

PRUEBA DE CONCEPTO “CORIVER”: IVERMECTINA COMO TRATAMIENTO ANTIVÍRICO EN PACIENTES INFECTADOS POR EL SARS-COV2 (COVID-19)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Pragmatic study "CORIVER": Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID19)

PRUEBA DE CONCEPTO “CORIVER”: IVERMECTINA COMO TRATAMIENTO ANTIVÍRICO EN PACIENTES INFECTADOS POR EL SARS-COV2 (COVID19)

A.3.2

Name or abbreviated title of the trial where available

CORIVER

A.4.1

Sponsor's protocol code number

CORIVER

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	Carmen Hidalgo
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	Hospital Universitario Virgen de las Nieves
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	Hospital Universitario Virgen de las Nieves
B.5.2	Functional name of contact point	Sergio Sequera
B.5.3	Address:
B.5.3.1	Street Address	Avd. Fuerzas Armadas 2
B.5.3.2	Town/ city	Granada
B.5.3.3	Post code	18014
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34958895414
B.5.6	E-mail	sergiosequera15@gmail.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	Yes
D.2.1.1.1	Trade name	Ivermectin
D.2.1.1.2	Name of the Marketing Authorisation holder	x
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Ivermectin
D.3.2	Product code	Ivermectin
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ivermectin
D.3.9.3	Other descriptive name	IVERMECTIN
D.3.9.4	EV Substance Code	SUB12089MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/kg microgram(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	200 to 400
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Dolquine
D.2.1.1.2	Name of the Marketing Authorisation holder	PRODUCTS AND TECHNOLOGY S.L.,
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	dolquine
D.3.2	Product code	Hydroxychloroquine
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Hydroxychloroquine
D.3.9.1	CAS number	118-42-3
D.3.9.4	EV Substance Code	SUB08077MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Azitromicina Vir 500 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Industria Química y Farmacéutica VIR, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	azithromycin
D.3.2	Product code	azithromycin
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	AZITHROMYCIN
D.3.9.3	Other descriptive name	AZITHROMYCIN
D.3.9.4	EV Substance Code	SUB05660MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
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	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

SARS-COV2

E.1.1.1

Medical condition in easily understood language

New Coronavirus infection

Infección por el 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 evaluate efficacy and safety of the use of Ivermectin in the treatment of SARS-COV2 ambulatory patients.

Evaluar la eficacia y seguridad del tratamiento con Ivermectina en el tratamiento de infección por SARS-COV2 ambulatorios.

E.2.2

Secondary objectives of the trial

To analyze clinical parameters
To evaluate the

1. To Analyze the improvement in clinical parameters (symptoms and physical examination).
2. To Assess the clinical cure rate after 2 weeks of treatment.
3. To Evaluate the microbiological cure rate 72 h after treatment.
4. To Assess the failure rate and admission requirements for disease progression.
5. To Analyze the factors of weak or poor response to ivermectin.
6. To Analyze adverse events to treatment.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients over 50 years of age with comorbidities, diagnosed with SARS-Cov 2 infection by PCR or another diagnostic test performed in the emergency department, who are in the first week of clinic, without pneumonia and without admission criteria.
• Patients between 18 and 70 years old (both inclusive) with pneumonia associated to SARS-Co2 infection: Cough or expectoration and / or fever> 38ºC + - Radiological infiltrate in Rxtórax; with SARS-Co2 PCR or radiological, clinical and analytical findings of COVID-19.
• Evolution time of initial symptoms between 3 and 8 days.
• Basal oxygen saturation> = 93% by breathing ambient air.
• Have signed the informed consent.

• Pacientes mayores de 50 años y comorbilidades con diagnóstico de infección por SARS-Cov 2 diagnosticados mediante PCR u otro test diagnóstico realizado en urgencias, que se encuentre en la primera semana de clínica, sin Neumonía y sin criterios de ingreso.
• Pacientes entre 18 y 70 años (ambos inclusive) con neumonía asociada a infección por SARS-Co2: Tos o expectoración y/o fiebre > 38ºC + - Infiltrado radiológico en Rxtórax; con PCR SARS-Co2 o hallazgos radiológicos, clínicos y analíticos de COVID-19.
• Tiempo de evolución de sintomatología inicial entre 3 y 8 días.
• Saturación basal de oxígeno >= 93% respirando aire ambiente.
• Que hayan firmado el consentimiento informado.

E.4

Principal exclusion criteria

• Patients with Pneumonia due to SARS-COV2 that requires hospital admission, due to multilobar involvement, respiratory failure P02 <93% ambient air or <92% for COPD patients; with analytical criteria of severity (D-dimer> 600, CRP> 50, lymphopenia <900, ferritin> 700 mg / dL, Il-6 or organ failure of the organ or who have significant comorbidities: Renal insufficiency> 3B; immunosuppression, cancer; chronic cirrhosis or liver disease, diabetes mellitus, atherosclerosis of any territory, heart rhythm disturbances (including prolonged QT), poorly controlled HT.
• Patients with QT range > 500ms.
• Patients under 18 years of age.
• Chilg-Pugh C liver failure.
• Impossibility of giving treatment for non-suppressible drugs with the risk of QT prolongation or interactions (antidepressants, antihistamines, quinolones, statins except pitavastatin) or allergy to the drug.
• Taking any of the drugs in the trial within 7 days prior to inclusion in the study
• Pregnancy, lactation

• Pacientes con Neumonía por SARS-COV2 que requiera ingreso hospitalario, por afectación multilobar, insuficiencia respiratoria P02 < 93% aire ambiente o <92% para pacientes EPOC; con criterios analíticos de gravedad (Dímero D >600, PCR >50, linfopenia< 900, ferritina >700 mg/dL, Il-6 o fracaso de órgano de órgano o que tengan comorbilidades significativas: Insuficiencia renal >3B; inmunosupresión, cáncer; cirrosis o hepatopatía crónica, diabetes mellitus, aterosclerosis de cualquier territorio, alteraciones del ritmo cardiaco (incluida QT prolongado), HTA mal controlada.
• Pacientes con QT >500ms.
• Pacientes menores de 18 años.
• Insuficiencia hepática Chilg-Pugh C.
• Imposibilidad de dar tratamiento por fármacos no suprimibles con riesgo de prolongación QT o interacciones (antidepresivos, antihistamínicos, quinolonas, estatinas salvo pitavastatina)o alergia al medicamento.
• Toma de alguno de los fármacos en ensayo de en los 7 días previos a la inclusión en el estudio
• Embarazo, lactancia

E.5 End points

E.5.1

Primary end point(s)

Efficacy will be measured by comparing clinical cure, Microbiology, need for hospital admission due to clinical or analytical, blood gas and / or radiological deterioration for each arm.

La eficacia se medirá comparando curación clínica, Microbiologia, necesidad de ingreso hospitalario por empeoramiento clínico o analítico, gasometrico y/o radiológico para cada brazo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Two weeks since the start of the tratment

A las dos semanas del inicio del tratamiento

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

Two weeks since the start of the tratment

A las dos semanas del inicio del tratamiento

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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)

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

Última visita del último paciente

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)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

2020-06-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-29

P. End of Trial
P.	End of Trial Status	Ongoing

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