Covid19, Liver Diseases
Conditions
Keywords
COVID-19, In-hospital mortality, Internal medicine
Brief summary
Of patients admitted to an internal medicine ward with internistic diagnosis/es together with COVID-19, substantial proportion has elevated liver enzymes. silymarin / silibinin (milk thistle extract) has been approved as an add-on therapy in various acute and chronic liver diseases; moreover, there is evidence to suggest that it's dual effect (anti-viral and immune-modulatory) might be of benefit in patients infected with SARS-CoV-2. As there is no effective/approved pharmacotherapy for COVID-19, a pilot study with Silymarine in hospitalised patients has been undertaken
Detailed description
According to the Bosch-Barrera et al. paper of 2021, silibinin in a daily dose of more than 1000 mg could improve clinical course of COVID-19 by its dual action: 1.direct inhibition of SARS-CoV-2 replication as well as 2.modulation of innate immune response - 2a. its initial (hyper)inflammation as well as 2b. later reparative phase, respectively. Moreover, the drug is known for its safety and has been approved and widely used in the region for liver diseases. Therefore, the investigation was set out to determine the efficacy of silymarin (compound closely related to Silibinin which is available in the region) in improving the outcome of a liver disease and of COVID-19, respectively.
Interventions
DRUGSilymarin
Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D
Sponsors
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective open label study using historical cohort for propensity-match analysis
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* consecutive, adult, admitted to an internal medicine ward with internistic diagnosis, together with COVID-19, and elevated liver enzymes (any of AST, ALT, GGT, ALP), provided written informed consent
Exclusion criteria
* too sick - terminal illness (no potential for recovery); critical condition on admission requiring immediate tracheal intubation; or any extra-pulmonary organ failure; completely vaccinated against COVID19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the COVID-19 stage of at least 1 point | During the hospital stay - up to around 21 days | Evolution of COVID-19 will be recorded according to a WHO criteria and reported as worsening (including death) / no change / improvement |
| Improvement in the activity of aminotranspherases | During the hospital stay - up to around 21 days | Change in the level of ALT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the diabetes control | During the hospital stay - up to around 21 days | Change in the glycemia |
| Improvement in the blood inflammatory markers | During the hospital stay - up to around 21 days | Change in C-reactive protein levels |
| Improvement in the dyspnea | During the hospital stay - up to around 21 days | Improvement of at least one point in the NYHA classification |
| Improvement in the acute kidney injury | During the hospital stay - up to around 21 days | Any improvement in the serum creatinine level |
Countries
Slovakia
Outcome results
None listed