Silymarin in COVID-19 Pneumonia
SCOPE
Trial of Silymarin in Adults With COVID-19 Pneumonia
1 other identifier
interventional
50
1 country
1
Brief Summary
A randomized placebo controlled trial to assess the clinical outcome in COVID-19 Pneumonia following administration of Silymarin owing to its role as a p38 MAPK pathway inhibitor and its antiviral, anti-inflammatory and anti-oxidant effects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedStudy Start
First participant enrolled
August 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedAugust 18, 2020
August 1, 2020
6 months
May 15, 2020
August 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to clinical improvement
Defined as the time from randomization to an improvement of two points (from the status of randomization) on seven category ordinal scale or live discharge from the hospital, whichever comes first.
7-28 days
Secondary Outcomes (5)
Clinical outcome
7-14 days
Duration of Mechanical Ventilation
Randomization till hospital discharge or death whichever came first, assessed up to 28 days
Hospitalization
Randomization till hospital discharge or death whichever came first, assessed up to 28 days
Virologic Response
Randomization till discharge, up to 28 days
Adverse events
Randomization till hospital discharge, up to 28 days
Study Arms (2)
Group 1
PLACEBO COMPARATORPatients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment plus placebo
Group 2
EXPERIMENTALpatients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + Silymarin Oral 420mg/day in 3 divided doses
Interventions
Eligibility Criteria
You may qualify if:
- COVID-19 patients with CT Chest-proven viral pneumonia with any degree of severity.
You may not qualify if:
- Patients \< 18 years of age.
- Patients with mild symptoms (as per WHO criteria) of SARS-CoV-2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Giza, Cairo Governorate, 12613, Egypt
Related Publications (2)
Liu CH, Jassey A, Hsu HY, Lin LT. Antiviral Activities of Silymarin and Derivatives. Molecules. 2019 Apr 19;24(8):1552. doi: 10.3390/molecules24081552.
PMID: 31010179BACKGROUNDLi D, Hu J, Wang T, Zhang X, Liu L, Wang H, Wu Y, Xu D, Wen F. Silymarin attenuates cigarette smoke extract-induced inflammation via simultaneous inhibition of autophagy and ERK/p38 MAPK pathway in human bronchial epithelial cells. Sci Rep. 2016 Nov 22;6:37751. doi: 10.1038/srep37751.
PMID: 27874084BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 19, 2020
Study Start
August 16, 2020
Primary Completion
January 30, 2021
Study Completion
February 28, 2021
Last Updated
August 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE