Clinical Trials Register

Summary
EudraCT Number:	2020-002119-23
Sponsor's Protocol Code Number:	IEO1253
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:	2020-09-22
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-002119-23

A.3

Full title of the trial

COVitaminD Trial: prevention of complications from COVID-19 in cancer patients under active treatment

COVitaminD Trial: prevenzione di complicanze da COVID-19 in pazienti oncologici in trattamento attivo

A.3.1

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

prevention of complications from COVID-19 in cancer patients under active treatment

prevenzione di complicanze da COVID-19 in pazienti oncologici in trattamento attivo

A.3.2

Name or abbreviated title of the trial where available

COVitaminD

A.4.1

Sponsor's protocol code number

IEO1253

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	ISTITUTO EUROPEO DI ONCOLOGIA
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	Bando per il finanziamento di progetti di ricerca in ambito sanitario REGIONE lOMBARDIA
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	ISTITUTO EUROPEO ONCOLOGIA
B.5.2	Functional name of contact point	UFFICIO STUDI CLINICI ED ATTIVITA'
B.5.3	Address:
B.5.3.1	Street Address	VIA RIPAMONTI 424/426
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20141
B.5.3.4	Country	Italy
B.5.4	Telephone number	0257489847
B.5.5	Fax number	0257489781
B.5.6	E-mail	ufficio.studiclinici@ieo.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	DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ABIOGEN PHARMA S.P.A.
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	DIBASE
D.3.2	Product code	[DIBASE]
D.3.4	Pharmaceutical form	Oral drops
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	COLECALCIFEROLO
D.3.9.2	Current sponsor code	DIBASE
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10000
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	Oral drops
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

Oncological patients in active oncological treatment diagnosed with Covid-19

Pazienti oncologici in trattamento attivo diagnosticati con Covid-19

E.1.1.1

Medical condition in easily understood language

Oncological patients in active oncological treatment diagnosed with Covid-19

Pazienti oncologici che stanno ricevendo un trattamento oncologico e che hanno ricevuto una diagnosi di Covid-19

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10010029
E.1.2	Term	Colorectal cancer NOS
E.1.2	System Organ Class	100000004864

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 aim of the study is to investigate whether supplement of vitamin D may assist in increasing the immunity response to Covid-19 infection, in cancer patients with no or minimal symptoms due to virus and not requiring hospitalization at baseline.

Lo scopo dello studio è di indagare se l'integrazione di vitamina D può aiutare ad aumentare la risposta immunitaria all'infezione da Covid-19, in pazienti con patologia oncologica attiva, con sintomi dovuti al virus assenti o minimi e che non richiedono ricovero al momento della diagnosi.

E.2.2

Secondary objectives of the trial

To investigate the prognostic factors of cancer patients with COVID-19 and identify prognostic biomarkers.

Studieremo i fattori prognostici dei malati di cancro con COVID-19 per identificare biomarcatori che possano indicare i soggetti a prognosi peggiore.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Covid-19 positive cancer patients in active treatment

malati di cancro in trattamento attivo (ovvero candidati all'attivazione o attualmente in trattamento con terapia sistemica o radioterapia o che hanno ricevuto un intervento chirurgico nell'ultimo mese)

E.4

Principal exclusion criteria

Hospitalized due to viral infection; current use of Vitamin D (these patients will not be randomized but they will be follow-up in the observational cohort study); history of recurrent renal calculi; history of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, Crohn disease, any chronic IBD); chronic liver disease and/or renal disease with altered biochemical functions, or renal dialysis; = grade 2 based on CTCAE (v 5.0); pregnancy or breast feeding or planning on becoming pregnant during the study; known hypersensitivity to vitamin D. Impossibility to swallow; nonmalignant alteration of calcium homeostasis

Ospedalizzazione a causa di infezione virale; uso corrente di vitamina D (questi pazienti non saranno randomizzati ma saranno seguiti nello studio di coorte osservazionale); storia di calcoli renali ricorrenti; storia di sindrome da malassorbimento (ad es. insufficienza pancreatica, celiachia, morbo di Crohn, qualsiasi IBD cronica); malattia epatica cronica e / o malattia renale con alterate funzioni biochimiche o dialisi renale; = grado 2 basato su CTCAE (v 5.0); gravidanza o allattamento o sta pianificando una gravidanza durante lo studio; ipersensibilità nota alla vitamina D; impossibilità di deglutire; alterazione non maligna dell'omeostasi del calcio.

E.5 End points

E.5.1

Primary end point(s)

Rate of hospitalization due to COVID-19 related pneumonia

Tasso di ricovero a causa di polmonite correlata a COVID-19.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month from the start of the treatment

1 mese dall’inizio del trattamento

E.5.2

Secondary end point(s)

Time to seroconversion; time spent in hospital; time without the need for oxygen therapy.
Prognostic scores: SOFA score, CURB-65, Hemophagocytic lymphohistiocytosis (HLH)
Radiological findings: Ground glass, local patchy, bilateral patchy, interstitial abnormalities, peripheral distribution, fine reticular opacity, vascular thickening.
Complications: pneumonia, ARDS, sepsis, coagulopathy, AKI, secondary infections, heart failure, access to intensity therapy care, death

Tempo di sieroconversione; tempo trascorso in ospedale; tempo senza la necessità di ossigenoterapia.Punteggi prognostici: punteggio SOFA (Sequential [Sepsis-Related] Organ Failure Assessment Score), CURB-65, linfoistiocitosi emofagocitica (HLH)
Risultati radiologici: vetro smerigliato, frammenti locali, chiazze bilaterali, anomalie interstiziali, distribuzione periferica, opacità reticolare fine, ispessimento vascolare.
Complicanze: polmonite, ARDS, sepsi, coagulopatia, AKI, infezioni secondarie, insufficienza cardiaca, accesso alle terapie di intensità, morte.

E.5.2.1

Timepoint(s) of evaluation of this end point

1 month from the start of the treatment

1 mese dall’inizio del trattamento

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

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

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

LVLS

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

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

F.4.2.2

In the whole clinical trial

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)

STANDARD TREARMENTS

PROGRAMMI DI ASSISTENZA STANDARD

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

2020-09-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-05-23

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