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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002119-23-IT

Enrollment

Registered

2020-09-22

Start date

2020-11-16

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncological patients in active oncological treatment diagnosed with Covid-19 MedDRA version: 21.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML Product Name: DIBASE Product Code: [DIBASE] Pharmaceutical Form: Oral drops INN or Proposed INN: COLECALCIFEROLO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Covid-19 positive cancer patients in active treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To investigate the prognostic factors of cancer patients with COVID-19 and identify prognostic biomarkers.;Primary end point(s): Rate of hospitalization due to COVID-19 related pneumonia;Timepoint(s) of evaluation of this end point: 1 month from the start of the treatment	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To investigate the prognostic factors of cancer patients with COVID-19 and identify prognostic biomarkers.;Primary end point(s): Rate of hospitalization due to COVID-19 related pneumonia;Timepoint(s) of evaluation of this end point: 1 month from the start of the treatment

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Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: 1 month from the start of the treatment	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: 1 month from the start of the treatment

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Countries

Italy

Contacts

Public ContactUFFICIO STUDI CLINICI ED ATTIVITA'

ISTITUTO EUROPEO ONCOLOGIA

ufficio.studiclinici@ieo.it0257489781

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026