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

Phase 4

Completed

• Conditions: Covid19; Liver Diseases
• Interventions: Drug: Silymarin

• Registration Number: NCT04816682
• Lead Sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

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.

Study Timeline

• Study Start: 2021-03-17
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LAGOSA ARM	Silymarin	Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2

Primary Outcome Measures

Name	Time	Method
Improvement in the activity of aminotranspherases	During the hospital stay - up to around 21 days	Change in the level of ALT
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

Secondary Outcome Measures

Name	Time	Method
Improvement in the blood inflammatory markers	During the hospital stay - up to around 21 days	Improvement in the interleukin - 6 level
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
Improvement in the diabetes control	During the hospital stay - up to around 21 days	Change in the glycemia

Trial Locations

Locations (2)

University Hospital Bratislava; 🇸🇰 Bratislava, Slovakia

F.D.Roosevelt Teaching Hospital; 🇸🇰 Banska Bystrica, Slovakia