Randomised clinical trial to test if silibinin administration can prevent the respiratory failure secondary to the COVID19 lung infection in oncologic patients.

Phase II Clinical Trial to evaluate the efficacy of silibinin supplementation in the prevention of the progression of the respiratory failure in patients with onco-hematological diseases and infection by COVID-19 positive. - SilCOVID19

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001794-77-ES

Enrollment

Registered

2020-07-22

Start date

2020-06-10

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

COVID19 respiratory failure

Interventions

Trade Name: LEGALON Pharmaceutical Form: Capsule INN or Proposed INN: Silibinin CAS Number: 22888-70-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Personal history of active cancer. Confirmed COVID19 current infection Age =18 years ECOG Performance Status =2 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 62 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: Not possibility of receiving oral drugs Hemodinamic inestability Patients requiring non invasive ventilation or FIO2> 50% Patient with a cancer survival prognosis <3 months for its oncologic disease.

Design outcomes

Primary

Measure	Time frame
Main Objective: To reduce proportion of patients requiring mechanical ventilation due to COVID19;Secondary Objective: Mortality, Safety and Biomarkers Identification;Primary end point(s): Proportion of patients requiring mechanical ventilation;Timepoint(s) of evaluation of this end point: Day 14th since the treatment onset	—

Secondary

Measure	Time frame
Secondary end point(s): Mortality rate;Timepoint(s) of evaluation of this end point: Day 30th since the treatment onset	—

Countries

Spain

Contacts

Public ContactClinical Research Unit

Catalan Institute of Oncology

bmartin@iconcologia.net

Outcome results

None listed

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