A Phase 4 interventional study of Silymarin in Covid19 and Liver Diseases, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Completed at 2 sites in Slovakia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Phase 4, Interventional, and Treatment
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 30 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2
Drug: Silymarin
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)
Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D
Also known as: LAGOSA
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
Time frame: During the hospital stay - up to around 21 days
Improvement in the activity of aminotranspherases
Change in the level of ALT
Time frame: During the hospital stay - up to around 21 days
Improvement in the diabetes control
Change in the glycemia
Time frame: During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Change in C-reactive protein levels
Time frame: During the hospital stay - up to around 21 days
Improvement in the dyspnea
Improvement of at least one point in the NYHA classification
Time frame: During the hospital stay - up to around 21 days
Improvement in the acute kidney injury
Any improvement in the serum creatinine level
Time frame: During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Improvement in the interleukin - 6 level
Time frame: During the hospital stay - up to around 21 days
Plan to share: Yes — Complete dataset will be shared on request under GDPR rules
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Dataset / protocol / ICF will be open for audit anytime Dataset will be shared after completion of upload
Access criteria: Journal editors Investigators - by the hypothesis testable on the dataset Auditing authority
Data sharing details ↗ · www.fnspfdr.sk
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Silymarin
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica