Clinical Trials Register

Summary
EudraCT Number:	2020-001806-42
Sponsor's Protocol Code Number:	CHOICE-19
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:	2021-01-25
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

2020-001806-42

A.3

Full title of the trial

ColcHicine in patients with COVID-19: a home CarE study

A.3.1

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

Trattamento con COLchicina di pazienti affetti da malattia da coronavirus (COVID-19): uno studio su pazienti domiciliari

A.3.2

Name or abbreviated title of the trial where available

Colchicine in COVID-19

A.4.1

Sponsor's protocol code number

CHOICE-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	SOCIETA' ITALIANA DI REUMATOLOGIA - SIR
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	Società Italiana di Medicina Generale e delle Cure Primarie
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Reumatologia
B.5.2	Functional name of contact point	Carlo Perricone
B.5.3	Address:
B.5.3.1	Street Address	Piazzale Menghini, 1
B.5.3.2	Town/ city	Perugia
B.5.3.3	Post code	06129
B.5.3.4	Country	Italy
B.5.4	Telephone number	0755783573
B.5.5	Fax number	0755783944
B.5.6	E-mail	carlo.perricone@unipg.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	Yes
D.2.1.1.1	Trade name	Colchicina LIRCA
D.2.1.1.2	Name of the Marketing Authorisation holder	ACARPIA Farmaceutici S.r.l.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Colchicina LIRCA
D.3.2	Product code	[009964038]
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	COLCHICINA
D.3.9.1	CAS number	64-86-8
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	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Yes
D.3.11.13.1	Other medicinal product type	farmaco antigottoso in grado di ridurre l’infiammazione

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Pazienti domiciliari con infezione sintomatica da SARS-CoV-2 che non richiedono ospedalizzazione.

E.1.1.1

Medical condition in easily understood language

Patologia caratterizzata da un’infezione sostenuta dal virus SARS-CoV-2 che può causare una polmonite accompagnata a febbre e tosse e richiedere il ricovero ospedaliero nel 18.7% dei casi circa.

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10068724
E.1.2	Term	Antiviral treatment
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10068724
E.1.2	Term	Antiviral treatment
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Riduzione del tasso di ospedalizzazione valutato a 30 giorni dalla randomizzazione.

E.2.2

Secondary objectives of the trial

1. Giorni di non necessità di ospedalizzazione
2. Tasso di mortalità
3. Tasso di guarigione clinica definito come scomparsa della sintomatologia e negativizzazione di due tamponi consecutivi a distanza di 24 ore
4. Effetti avversi legati al trattamento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Qualsiasi sesso
2. Età uguale o maggiore di 18 anni
3. Consenso informato per la partecipazione allo studio
4. Diagnosi virologica dell'infezione da SARS-CoV-2 (RT-PCR) con tampone positivo determinato entro le 96 ore precedenti alla randomizzazione
5. Comparsa del primo sintomo associato all'infezione da SARS-CoV-2 entro 10 giorni dalla randomizzazione
6. Presenza di almeno 2 dei seguenti:
a. Febbre uguale o maggiore a 37 °C
b. Frequenza respiratoria a riposo = 19 =23
c. Saturazione O2 a riposo in aria ambiente >94%
d. Sintomatologia: tosse secca, dispnea, faringodinia, disgeusia, anosmia, bruciore oculare, artromialgie o diarrea

E.4

Principal exclusion criteria

1. Ipersensibilità nota alla colchicina o ai suoi eccipienti
2. Pazienti che non possono assumere la terapia orale
3. Pazienti in gravidanza e in allattamento
4. Pazienti ospedalizzati o con indicazione immediata al ricovero
5. Paziente con preesistente malattia neuromuscolare progressiva e CPK> 2 volte i limiti normali
6. Pazienti con grave insufficienza cardiaca, renale (tasso di filtrazione glomerulare stimato (eGFR), utilizzando l'equazione MDRD o (EPI CKD) per tutti i soggetti considerati per l'arruolamento, con un limite di <30 mL / min / 1,73 m2)
7. Paziente con anamnesi di cirrosi, epatite cronica attiva o grave malattia epatica;
8. Paziente che sta attualmente assumendo colchicina per altre indicazioni (gotta, pericardite, febbre mediterranea familiare, altre malattie autoinfiammatorie)
9. Pazienti con assumono farmaci che hanno forte interazione con l'enzima CYP3A4 o con glicoproteina P (inclusi lopinavir, ritonavir, darunavir/cobicistat, ketoconazolo, ciclosporina, verapamil, chinidina e claritromicina)
10. Altre condizioni cliniche note che controindicano l’uso della colchicina e non possono essere trattate o risolte secondo il giudizio del medico
11. Pazienti con anamnesi nota di neutropenia (neutrofili <1.000 / mmc) e trombocitopenia (piastrine <50.000 / mmc)
12. Pazienti con malattia infiammatoria intestinale e diverticolite
13. Pazienti già arruolati in altri studi clinici

E.5 End points

E.5.1

Primary end point(s)

Riduzione del tasso di ospedalizzazione valutato a 30 giorni dalla randomizzazione.

E.5.1.1

Timepoint(s) of evaluation of this end point

30 giorni.

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

30 giorni.

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Terapia standard

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

Information not present in EudraCT

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

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:

219

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

219

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

438

F.4.2

For a multinational trial

F.4.2.1

In the EEA

438

F.4.2.2

In the whole clinical trial

438

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)

I pazienti verranno seguiti domiciliarmente per valutarne l’andamento clinico mediante intervista telefonica.

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

2020-05-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-05-18

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-01-18

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