Randomised clinical trial to test if silibinin administration can prevent the respiratory failure secondary to the COVID19 lung infection in oncologic patients.
Phase 1
- Conditions
- COVID19 respiratory failureTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001794-77-ES
- Lead Sponsor
- INSTITUT CATALÀ D'ONCOLOGIA GIRONA - HOSPITAL JOSEP TRUETA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 92
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Mortality rate;Timepoint(s) of evaluation of this end point: Day 30th since the treatment onset