Clinical Trials Register

Summary
EudraCT Number:	2020-002283-32
Sponsor's Protocol Code Number:	2020-34
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-08-10
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002283-32

A.3

Full title of the trial

Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the early Treatment of COVID-19

Studio clinico randomizzato, in doppio cieco, multicentrico, di fase II, Proof of Concept, Dose Finding sull'impiego dell'Ivermectina per il trattamento precoce del COVID-19

A.3.1

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

Randomized, Double-blind, Multi Centre Phase II, Dose Finding Clinical Trial on Ivermectin for the early Treatment of COVID-19

Studio clinico randomizzato, in doppio cieco, multicentrico, di fase II, per l'individuazione del dosaggio di impiego dell'Ivermectina per il trattamento precoce del COVID-19

A.3.2

Name or abbreviated title of the trial where available

COVER

A.4.1

Sponsor's protocol code number

2020-34

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	OSPEDALE CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO
B.1.3.4	Country	Italy
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	Laboratorios Liconsa (Chemo Group)
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	IRCCS Sacro Cuore Don Calabria
B.5.2	Functional name of contact point	Unità per la Ricerca Clinica
B.5.3	Address:
B.5.3.1	Street Address	Via Don A. Sempreboni, 5
B.5.3.2	Town/ city	Negrar di Valpolicella (VR)
B.5.3.3	Post code	37024
B.5.3.4	Country	Italy
B.5.4	Telephone number	0456014854
B.5.6	E-mail	ricerca.clinica@sacrocuore.it

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	Ivermectina
D.3.2	Product code	[-]
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.3.9.1	CAS number	70288-86-7
D.3.9.2	Current sponsor code	-
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	9
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	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	Ivermectina
D.3.2	Product code	[-]
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.3.9.1	CAS number	70288-86-7
D.3.9.2	Current sponsor code	-
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	9
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

COVID-19

E.1.1.1

Medical condition in easily understood language

COVID-19

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10053983
E.1.2	Term	Corona virus infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The study is aimed:
1) at defining if ivermectin, administered at dosage of 600 µg/kg or 1200 µg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection,
2) at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7.

Lo studio è inteso a:
1. definire se l'ivermectina, somministrata alla dose di 600 mcg/kg o 1200 mcg/kg QD per cinque giorni consecutivi è sicura nei pazienti con infezione SARS_CoV2 iniziale, asintomatica o paucisintomatica e:
2. definire se l'ivermectina, somministrata al dosaggio (i) trovato (i) sicuro, riduce la carica virale di SARS-CoV2 al 7 ° giorno.

E.2.2

Secondary objectives of the trial

Secondary objectives
To assess
1. the temporal profile of viral load at baseline, day 7, 14 and 30
2. the time to clinical cure (for symptomatic patients)
3. the proportion of patients with virological clearance at day 14 and 30.
4. the hospitalization rate.
5. the COVID-19 Severity Score at day 14 and 30

Valutare
1. il profilo temporale della carica virale al basale e ai giorni 7, 14 e 30
2. il tempo di remissione clinica (per i pazienti sintomatici)
3. la percentuale di pazienti con clearance virologica al giorno 14 e 30
4. il tasso di ospedalizzazione
5. il COVID-19 Severity Score ai giorni 14 e 30

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Pharmacokynetics study - Vers. 1.0 - 01.05.2020 - Objective: to evaluate the association between plasma drug concentration and clinical endpoints

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio di Farmacocinetica - Vers. 1.0 - 01.05.2020 - Obiettivo: valutare l'associazione tra le concentrazioni plasmatiche del farmaco e gli endpoint clinici.

E.3

Principal inclusion criteria

• Age (>=18 years)
• Positivity at RT-PCR per SARS_CoV-2 (nasopharyngeal swabs)
• COVID-19 Severity Score < 3
• Patient able to take oral drugs
• Informed consent to study participation and to personal data treatment

Criterio di inclusione
• Età (> = 18 anni)
• Positività a RT-PCR per SARS_CoV2 (tampone nasofaringeo)
• COVID-19 Severity Score <3
• Paziente in grado di assumere farmaci per via orale
• Consenso alla partecipazione allo studio e al trattamento dei dati personali

E.4

Principal exclusion criteria

Exclusion criteria:
• Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded)
• Subjects suffering from known CNS diseases
• Lack of (or inability to provide) informed consent
• Patient under dialysis
• Any severe medical condition with a prognosis of < 6 months
• Patients under warfarin treatment
• Patients under antiviral treatment
• Patients under chloroquine phosphate or hydroxychloroquine

Criteri di esclusione
• Donne in gravidanza o in allattamento (non è richiesto il test di gravidanza, in caso di dubbio la paziente viene esclusa)
• Soggetti che soffrono di malattie del SNC note
• Mancanza (o incapacità di fornire) un consenso informato
• Paziente in dialisi
• Qualsiasi condizione medica grave con una prognosi inferiore a 6 mesi
• Pazienti in trattamento con warfarin
• Pazienti sottoposti a trattamento antivirale
• Pazienti in trattamento con clorochina fosfato o idrossiclorochina

E.5 End points

E.5.1

Primary end point(s)

1. Number of serious adverse drug reaction (SADR).
2. Quantitative viral load at Day 7 as measured by quantitative, digital droplet PCR.

NB: The primary outcome no.2., as well as all secondary outcomes, will be measured only if the number of SADR is less than 4 in at least one of the treatment arms.

1. numero di reazioni avverse gravi al farmaco (SADR)
2. Carica virale quantitativa al giorno 7, misurata mediante PCR digitale

Nota: L'endpoint primario n. 2 e gli endpoints secondari verranno valutati solo se il numero delle SADR sarà inferiore a 4 in almeno uno dei bracci di trattamento.

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 14

GIorno 14

E.5.2

Secondary end point(s)

Trend over time of quantitative viral load at Day 7, 14 and Day 30 as measured by quantitative, digital droplet PCR.; Time to clinical resolution (for symptomatic patients).; Proportion of patients with virological clearance at day 14 and 30; Rate of hospitalization.; COVID-19 Severity Score at Day 14 and Day 30

Andamento nel tempo della carica virale misurata mediante PCR quantitativa digitale ai giorni 7, 14 e 30; Tempo alla guarigione clinica (per i pazienti sintomatici); Percentuale di pazienti con clearance virale ai giorni 14 e 30; Tasso di ospedalizzazione; COVID-19 Severity Score ai giorni 14 e 30

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 7, 14 and 30; During the follow-up period; Day 14 and 30; During the follow-up period; Day 14 and 30

Giorni 7,14 e 30; Durante i 30 giorni di follow-up; Giorni 14 e 30; Durante tutto il periodo di follow-up.; Giorni 14 e 30

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

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)

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Information not present in EudraCT

E.8.7

Trial 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

LPLV

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-08-10.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

122

F.4.2.2

In the whole clinical trial

122

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-06-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-28

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-06-29

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