Clinical trial NCT04816682: Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes
Official title: Does Silymarin Mitigate Clinical Course of COVID-19 in Patients Admitted to an Internal Medicine Ward With Elevated Liver Enzymes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covid19
Liver Diseases
Keywords: COVID-19
In-hospital mortality
Internal medicine
Lead sponsor: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Prospective open label study using historical cohort for propensity-match analysis
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in the COVID-19 stage of at least 1 point
timeFrame: During the hospital stay - up to around 21 days
measure: Improvement in the activity of aminotranspherases
timeFrame: During the hospital stay - up to around 21 days
Secondary outcomes:
measure: Improvement in the diabetes control
timeFrame: During the hospital stay - up to around 21 days
measure: Improvement in the blood inflammatory markers
timeFrame: During the hospital stay - up to around 21 days
measure: Improvement in the dyspnea
timeFrame: During the hospital stay - up to around 21 days
measure: Improvement in the acute kidney injury
timeFrame: During the hospital stay - up to around 21 days
measure: Improvement in the blood inflammatory markers
timeFrame: During the hospital stay - up to around 21 days
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: F.D.Roosevelt Teaching Hospital
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava
Study officials:
affiliation: Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
name: Lubomir SKLADANY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.