Covid19Phase 4SILCOVINT-21NCT04816682
Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes
A Phase 4 study testing Silymarin in people with Covid19 and Liver Diseases, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 2 sites in Slovakia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Covid19, Liver Diseases
- What is being tested?
- Silymarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesSlovakia
- Study dates
- 17 Mar 2021to 30 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
F.D.Roosevelt Teaching Hospital
Banská Bystrica, 97401
University Hospital Bratislava
Bratislava, 82101
About this study
Official title: 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
Read the 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.
- Conditions
- Covid19, Liver Diseases
- Being tested
- Silymarin
- Keywords
- COVID-19, In-hospital mortality, Internal medicine
- Medical subject headings
- COVID-19, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
Also called LAGOSA
Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D
| Study group | Role | What they receive |
|---|---|---|
| LAGOSA ARM | Active comparator | Consecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the hospital stay - up to around 21 days
Improvement in the activity of aminotranspherases
Change in the level of ALT
Measured: During the hospital stay - up to around 21 days
Secondary outcomes (5)
Improvement in the diabetes control
Change in the glycemia
Measured: During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Change in C-reactive protein levels
Measured: During the hospital stay - up to around 21 days
Improvement in the dyspnea
Improvement of at least one point in the NYHA classification
Measured: During the hospital stay - up to around 21 days
Improvement in the acute kidney injury
Any improvement in the serum creatinine level
Measured: During the hospital stay - up to around 21 days
Improvement in the blood inflammatory markers
Improvement in the interleukin - 6 level
Measured: During the hospital stay - up to around 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start17 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective open label study using historical cohort for propensity-match analysis
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ľubomír Skladaný MD, PhD, F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
- Investigators
- Lubomir SKLADANY, MD, PhD, Principal investigator, Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816682
- Sponsor's protocol ID
- SIL-COVINT-21
- Acronym
- SILCOVINT-21
- Status last verified
- Aug 2022
- First submitted
- 19 Mar 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete dataset will be shared on request under GDPR rules
Publications
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.
PubMed 32517353
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Silymarin Mitigate Clinical Course of COVID-19 in Patients Admitted to an Internal Medicine Ward With Elevated Liver Enzymes?
- ClinicalTrials.gov ID
- NCT04816682
- Acronym / sponsor ID
- SILCOVINT-21 / SIL-COVINT-21
- Conditions
- Covid19, Liver Diseases
- Keywords
- COVID-19, In-hospital mortality, Internal medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska BystricaUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective open label study using historical cohort for propensity-match analysis
| Arm | Type | Receives |
|---|---|---|
| LAGOSA ARM | Active comparator | Drug: SilymarinConsecutively admitted patients will be allocated silymarin tablets (150 mg each) T.I.D. 3-2-2 |
| 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilymarinAlso: LAGOSASilymarine tablets will be provided irrespective of meal by a registered nurse T.I.D | Drug | LAGOSA ARM |
Primary outcome
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
Improvement in the activity of aminotranspherases
Time frame: During the hospital stay - up to around 21 days
Change in the level of ALT
5 secondary outcomes
Improvement in the diabetes control
Time frame: 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 dyspnea
Time frame: 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
Improvement in the blood inflammatory markers
Time frame: During the hospital stay - up to around 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Results publication: PubMed 32517353Bosch-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.
- Individual participant dataSharing planned: Yes. Complete dataset will be shared on request under GDPR rules
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lubomir SKLADANY, MD, PhD principal investigator
Study Principal Investigator F.D.Roosevelt Teaching Hospital, Banska Bystrica, Slovakia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silymarin in people with Covid19 and Liver Diseases, run by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica at 2 sites in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the COVID-19 stage of at least 1 point (time frame: During the hospital stay - up to around 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.