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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAGOSA ARM | Active Comparator | Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2 |
|
| Control arm | No Intervention | Consecutive patients with the same inclusion/exclusion criteria as in active arm, hospitalised at the same department before the initiation of the study (historical controls) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silymarin | Drug | Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the COVID-19 stage of at least 1 point | Evolution of COVID-19 will be recorded according to a WHO criteria and reported as worsening (including death) / no change / improvement | During the hospital stay - up to around 21 days |
| Improvement in the activity of aminotranspherases | Change in the level of ALT | During the hospital stay - up to around 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the diabetes control | Change in the glycemia | During the hospital stay - up to around 21 days |
| Improvement in the blood inflammatory markers | Change in C-reactive protein levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lubomir SKLADANY, MD, PhD | Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.D.Roosevelt Teaching Hospital | Banská Bystrica | 97401 | Slovakia | |||
| University Hospital Bratislava |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32517353 | Result | Bosch-Barrera J, Martin-Castillo B, Buxo M, Brunet J, Encinar JA, Menendez JA. Silibinin and SARS-CoV-2: Dual Targeting of Host Cytokine Storm and Virus Replication Machinery for Clinical Management of COVID-19 Patients. J Clin Med. 2020 Jun 7;9(6):1770. doi: 10.3390/jcm9061770. |
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Complete dataset will be shared on request under GDPR rules
Dataset / protocol / ICF will be open for audit anytime Dataset will be shared after completion of upload
Journal editors Investigators - by the hypothesis testable on the dataset Auditing authority
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012838 | Silymarin |
| D000077385 | Silybin |
| ID | Term |
|---|---|
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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Prospective open label study using historical cohort for propensity-match analysis
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| During the hospital stay - up to around 21 days |
| Improvement in the dyspnea | Improvement of at least one point in the NYHA classification | During the hospital stay - up to around 21 days |
| Improvement in the acute kidney injury | Any improvement in the serum creatinine level | During the hospital stay - up to around 21 days |
| Improvement in the blood inflammatory markers | Improvement in the interleukin - 6 level | During the hospital stay - up to around 21 days |
| Bratislava |
| 82101 |
| Slovakia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |