Clinical Trials Register

Summary
EudraCT Number:	2020-001258-23
Sponsor's Protocol Code Number:	ColCOVID19
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2020-04-20
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-001258-23

A.3

Full title of the trial

COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA

COLCHICINA PER CONTRASTARE LA RISPOSTA INFIAMMATORIA IN CORSO DI POLMONITE DA COVID 19

A.3.1

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

COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA

COLCHICINA PER CONTRASTARE LA RISPOSTA INFIAMMATORIA IN CORSO DI POLMONITE DA COVID 19

A.3.2

Name or abbreviated title of the trial where available

ColCOVID19

A.4.1

Sponsor's protocol code number

ColCOVID19

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04322565

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	AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
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	AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
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	AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA
B.5.2	Functional name of contact point	CORRADO CONFALONIERI Segreteria CE
B.5.3	Address:
B.5.3.1	Street Address	VIA GRAMSCI
B.5.3.2	Town/ city	PARMA
B.5.3.3	Post code	43126
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390521703013
B.5.6	E-mail	cconfalonieri@ao.pr.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
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
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.3.11 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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients with COVID-19 infection with pneumonia and stable conditions.

infezione da COVID-19 con polmonite e condizioni clinicamente stabili

E.1.1.1

Medical condition in easily understood language

patients with COVID-19 infection with pneumonia and stable conditions.

infezione da COVID-19 con polmonite e condizioni clinicamente stabili

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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 the clinical efficacy of colchicine relative to the control arm in adult patients hospitalized for COVID-19 with pneumonia and clinically stable conditions

Valutare l'efficacia clinica della colchicina relativamente al trattamento standard in pazienti adulti ospedalizzati con polmonite da COVID-19 e in condizioni clinicamente stabili

E.2.2

Secondary objectives of the trial

- Clinical efficacy of colchicine compared to the control arm by clinical severity
- Duration of predefined symptoms and signs (if applicable)
- Duration of supplemental oxygen dependency (if applicable)
- Incidence of new mechanical ventilation use during the study
- Duration of new mechanical ventilation use during the Study
- Need for admission into intensive care unit (ICU)
- Evaluate duration of hospitalization (days)
- Evaluate the 28-day mortality rate

- Efficacia clinica della colchicina confrontata con il braccio di controllo in base alla severità clinica
- Durata di sintomi e segni predefiniti (se applicabile)
-Durata della dipendenza da supplementazione di ossigeno (se applicabile)
- Incidenza dell'uso di nuova ventilazione meccanica durante lo studio
- Durata dell'uso di nuova ventilazione meccanica durante lo studio
- Necessità di ricovero in unità di terapia intensiva

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients aged 18 years or above
- Belonging to the low- to intermediate-risk strata according to the criteria of the Emilia-Romagna Region, Italy (PG/2020/0240975 del 21 marzo 2020 “Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19”, Scenario 2 and 3A, in a scale of increased levels of severity) and to the SIMIT guidelines (http://www.simit.org/IT/formazione/linee-guida.xhtml)), that is patients in stable medical conditions (MEWS<3, see Table below) with the following characteristics:

-Pauci-symptomatic with positive nasopharyngeal swab for COVID-19 + age ≥70 years and/or clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) + even minimal CT scan findings (>5% of lung parenchima) suggestive of viral pneumonia (ground-glass opacities and/or patchy consolidation, and/or interstitial changes with a peripheral distribution)

- Symptomatic (temperature ≥38°C and/or intensive cough and/or shortness of breath), + CT imaging showing typical findings of viral pneumonia (ground-glass opacities, multifocal patchy consolidation, and/or interstitial changes with a peripheral distribution) and positive or pending pharyngo-nasal swab for COVID-19.

Pazienti di età uguale o maggiore di 18 anni
Appartenenti al gruppo di rischio basso-intermedio, in base ai criteri della Regione Emilia-Romagna, Italia (PG/2020/0240975 del 21 marzo 2020 "Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19", Scenario 2 e 3A, in una scala di livelli aumentati di gravità) e alle linee guida SIMIT (http://www.simit.org/IT/formazione/linee-guida.xhtml), cioè pazienti in condizioni mediche stabili (MEWS<3) con le seguenti caratteristiche:
- Pauci-sintomatici con tampone nasofaringeo positivo per COVID-19 + età ?70 anni e/o fattori di rischio clinico per outcome mediocre (malattia polmonare cronica clinicamente rilevante, diabete e /o cardiopatia) + reperti alla TC anche minimi (>5% di parenchima polmonare) suggestivi di polmonite virale
- Sintomatici (temperatura ?38°C e/o tosse persistente e/o dispnea), + immagini alla TC che mostrano reperti tipici di polmonite virale e tampone faringonasale positivo per COVID-19 o in attesa di conferma.

E.4

Principal exclusion criteria

- Unstable clinical conditions (MEWS≥3)
- Respiratory rate > 30 rpm, PaO2/FiO2 < 200mmHg
- Pregnant or breast feeding
- Hepatic failure Child-Pugh C
- Enrollment in other pharmacological studies
Treatment with
- Chronic treatment with colchicine
- Ongoing treatment with antiviral drugs that include ritonavir or cobicistat (Previous treatment with antiviral drugs that include ritonavir or cobicistat is NOT an exclusion criteria)
- Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.

- Condizioni cliniche instabili (MEWS≥3)
- Frequenza respiratoria > 30 rpm, PaO2/FiO2 < 200mmHg
- In gravidanza o in allattamento
- Insufficienza epatica Child-Pugh C
- Arruolamento in altri studi farmacologici
In trattamento con
- Terapia cronica con colchicina
- Terapia in atto con farmaci antivirali comprendente ritonavir o cobicistat (la terapia pregressa con farmaci antivirali comprendente ritonavir o cobicistat non è un criterio di esclusione)
- Qualunque condizione medica o patologia che, secondo il Ricercatore potrebbe mettere il paziente a rischio inaccettabile per la partecipazione allo studio.

E.5 End points

E.5.1

Primary end point(s)

Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale (cfr 7.5.2) or live discharge from the hospital (whatever comes first) as recommended by Coronavirus Disease (COVID – 2019) R&D Geneva World Health Organization http://www.who.int/

Tempo al miglioramento clinico: definito come tempo dalla randomizzazione a un miglioramento di due punti rispetto allo stato al momento della randomizzazione su una scala ordinale di sette categorie, o come dimissione dall'ospedale di paziente in vita (il caso che si verifica per primo) come raccomandato dal Coronavirus Disease (COVID - 2019) R&D Geneva World Health Organization http://www.who.int/

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days

28 giorni

E.5.2

Secondary end point(s)

1. Clinical status as assessed with 7-category ordinal scale on days 7 and 14
2. Mortality at day 28
3. Duration of mechanical ventilation
4. Duration of hospitalization in survivors
5. Time in days from treatment initiation to death
6. Time for negativeization of two consecutive pharyngo-nasal swab 24-72 hrs apart
7. Time to remission of fever in patients with T>37.5°C at enrollment

1. valutazione della scala ordinale a 7 e 14 giorni
2. mortalità a 28 giorni
3. durata di ventilazione meccanica
4. durata di ospedalizzazione nei sopravvissuti
5. Tempo in giorni dall'inizio della terapia alla morte
6. Tempo di negativizzazione di due tamponi naso-faringei consecutivi a distanza di 24-72 ore
7. Tempo di remissione della febbre in pazienti con T> 37,5 ° C al momento dell'arruolamento

E.5.2.1

Timepoint(s) of evaluation of this end point

28 days

28 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

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

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

SOC Standard of Care

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

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

LVLS

Ultima visita dell'ultimo paziente

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

Yes

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

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

for the severity of the clinical condition or in the case of legal representative of the patient

per la severità della condizione clinica o nel caso di tutore legale

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

310

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)

SOC Standard of care

Trattamento Standrd

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

2020-04-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-04-20

P. End of Trial
P.	End of Trial Status	Completed

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