Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes

Covid19 Clinical Trial

— SILCOVINT-21  

Official title:

Does Silymarin Mitigate Clinical Course of COVID-19 in Patients Admitted to an Internal Medicine Ward With Elevated Liver Enzymes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816682
• Other study ID #: SIL-COVINT-21
• Status: Completed
• Phase: Phase 4
• Start date: March 17, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Liver Diseases

Intervention

Drug:
• Silymarin
Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D

Locations

Country	Name	City	State
Slovakia	F.D.Roosevelt Teaching Hospital	Banska Bystrica
Slovakia	University Hospital Bratislava	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Country where clinical trial is conducted

Slovakia, 

References & Publications (1)

Bosch-Barrera J, Martin-Castillo B, Buxó 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). pii: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Improvement in the activity of aminotranspherases	Change in the level of ALT	During the hospital stay - up to around 21 days
Secondary	Improvement in the diabetes control	Change in the glycemia	During the hospital stay - up to around 21 days
Secondary	Improvement in the blood inflammatory markers	Change in C-reactive protein levels	During the hospital stay - up to around 21 days
Secondary	Improvement in the dyspnea	Improvement of at least one point in the NYHA classification	During the hospital stay - up to around 21 days
Secondary	Improvement in the acute kidney injury	Any improvement in the serum creatinine level	During the hospital stay - up to around 21 days
Secondary	Improvement in the blood inflammatory markers	Improvement in the interleukin - 6 level	During the hospital stay - up to around 21 days