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Trial - EUCTR2020-002119-23-IT


Column Value
Trial registration number EUCTR2020-002119-23-IT
Full text link
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002119-23/IT

First author
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

ISTITUTO EUROPEO ONCOLOGIA - UFFICIO STUDI CLINICI ED ATTIVITA'

Contact
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

ufficio.studiclinici@ieo.it

Registration date
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

2020-09-22

Recruitment status
Last imported at : March 7, 2024, 8 a.m.
Source : EU Clinical Trials Register

Terminated

Study design
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

RCT

Allocation
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Randomized

Design
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Parallel

Masking
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Blind label

Center
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

multi-center

Study aim
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Treatment

Inclusion criteria
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

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)

Exclusion criteria
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

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.

Number of arms
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

2

Funding
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

ISTITUTO EUROPEO DI ONCOLOGIA

Inclusion age min
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

18

Inclusion age max
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

100

Countries
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Italy

Type of patients
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Mild disease at enrollment

Severity scale
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

1: Mild disease at enrollment

Total sample size
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

80

primary outcome
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Rate of hospitalization due to COVID-19 related pneumonia Tasso di ricovero a causa di polmonite correlata a COVID-19.

Notes
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Declared number of arm (3.0) differs from found arms (2.0)

Phase
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

Phase 2

Arms
Last imported at : Dec. 1, 2020, 11:55 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]