Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes (SILCOVINT-21)

August 2, 2022 updated by: Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • F.D.Roosevelt Teaching Hospital
      • Bratislava, Slovakia, 82101
        • University Hospital Bratislava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LAGOSA ARM
Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2
Drug: Silymarin
Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D
Other Names:
  • LAGOSA
No Intervention: Control arm
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the COVID-19 stage of at least 1 point
Time Frame: 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
During the hospital stay - up to around 21 days
Improvement in the activity of aminotranspherases
Time Frame: During the hospital stay - up to around 21 days
Change in the level of ALT
During the hospital stay - up to around 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in the diabetes control
Time Frame: During the hospital stay - up to around 21 days
Change in the glycemia
During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Time Frame: During the hospital stay - up to around 21 days
Change in C-reactive protein levels
During the hospital stay - up to around 21 days
Improvement in the dyspnea
Time Frame: During the hospital stay - up to around 21 days
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
Time Frame: During the hospital stay - up to around 21 days
Any improvement in the serum creatinine level
During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Time Frame: During the hospital stay - up to around 21 days
Improvement in the interleukin - 6 level
During the hospital stay - up to around 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Investigators

  • Principal Investigator: Lubomir SKLADANY, MD, PhD, Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL-COVINT-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Complete dataset will be shared on request under GDPR rules

IPD Sharing Time Frame

Dataset / protocol / ICF will be open for audit anytime Dataset will be shared after completion of upload

IPD Sharing Access Criteria

Journal editors Investigators - by the hypothesis testable on the dataset Auditing authority

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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