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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-12-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Covid19 Liver Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LAGOSA ARM

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

Group Type ACTIVE_COMPARATOR

Silymarin

Intervention Type DRUG

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

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Silymarin

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

Intervention Type DRUG

Other Intervention Names

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LAGOSA

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No