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

NCT04816682 | Completed Phase 4 DMC

• 1 other identifier: SIL-COVINT-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Covid19; Liver Diseases

Keywords

COVID-19; In-hospital mortality; Internal medicine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Improvement in the diabetes control

  During the hospital stay - up to around 21 days

• Improvement in the blood inflammatory markers

  During the hospital stay - up to around 21 days

• Improvement in the dyspnea

  During the hospital stay - up to around 21 days

• Improvement in the acute kidney injury

  During the hospital stay - up to around 21 days

• Improvement in the blood inflammatory markers

  During the hospital stay - up to around 21 days

Study Arms (2)

LAGOSA ARM

ACTIVE COMPARATOR

Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2

Drug: Silymarin

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)

Interventions

Silymarin DRUG

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

Also known as: LAGOSA

LAGOSA ARM

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: lead

Study Sites (2)

F.D.Roosevelt Teaching Hospital

Banská Bystrica, 97401, Slovakia

Location

University Hospital Bratislava

Bratislava, 82101, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 32517353 RESULT

MeSH Terms

Conditions

COVID-19; Liver Diseases

Interventions

Silymarin; Silybin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Lubomir SKLADANY, MD, PhD

  Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Internal Medicine and HEGITO Liver Unit, Principal Investigator

Model Details: Prospective open label study using historical cohort for propensity-match analysis

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: March 17, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

SL (2)