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Completed

NCT Number: NCT04816682

Silymarin in COVID-19 Patients Admitted to Hospital 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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Digestive System Diseases Infections Liver Diseases Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

F.D.Roosevelt Teaching Hospital, Banská Bystrica, Slovakia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silymarin

Drug

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

Other names: LAGOSA

Primary outcomes

  1. 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

  2. Improvement in the activity of aminotranspherases

    Time frame: During the hospital stay - up to around 21 days

    Change in the level of ALT

Secondary outcomes

  1. Improvement in the diabetes control

    Time frame: During the hospital stay - up to around 21 days

    Change in the glycemia

  2. Improvement in the blood inflammatory markers

    Time frame: During the hospital stay - up to around 21 days

    Change in C-reactive protein levels

  3. 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

  4. Improvement in the acute kidney injury

    Time frame: During the hospital stay - up to around 21 days

    Any improvement in the serum creatinine level

  5. Improvement in the blood inflammatory markers

    Time frame: During the hospital stay - up to around 21 days

    Improvement in the interleukin - 6 level

Sponsors and collaborators

Lead sponsor

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Other

Registry information

Official study title

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

Acronym: SILCOVINT-21

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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