Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Silymarin in COVID-19 Pneumonia (SCOPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394208
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Khaled Mohammed Korany Salem, Cairo University

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

Condition or disease Intervention/treatment Phase
COVID-19 Viral Pneumonia Human Coronavirus Drug: Silymarin Drug: Placebo Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1 (Control): Includes 25 patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + placebo Group 2 (Intervention): Includes 25 patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + Silymarin Oral at a dose of 420 mg/day in 3 divided doses.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Trial of Silymarin in Adults With COVID-19 Pneumonia
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Silymarin

Arm Intervention/treatment
Placebo Comparator: Group 1
Patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment plus placebo
Drug: Placebo
Placebo comparator

Experimental: Group 2
patients with COVID-19 pneumonia receiving standard of care as per Ministry of Health Protocol of Treatment + Silymarin Oral 420mg/day in 3 divided doses
Drug: Silymarin
Silymarin Oral at a dose of 420 mg/day in 3 divided doses.




Primary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 7-28 days ]
    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.


Secondary Outcome Measures :
  1. Clinical outcome [ Time Frame: 7-14 days ]
    Clinical status as assessed with the seven-category ordinal scale on days 7 and 14

  2. Duration of Mechanical Ventilation [ Time Frame: Randomization till hospital discharge or death whichever came first, assessed up to 28 days ]
    Time in days patient was intubated

  3. Hospitalization [ Time Frame: Randomization till hospital discharge or death whichever came first, assessed up to 28 days ]
    Total days of hospitalization

  4. Virologic Response [ Time Frame: Randomization till discharge, up to 28 days ]
    number of days patient remained with positive RT-PCR SARS-CoV-2 swab

  5. Adverse events [ Time Frame: Randomization till hospital discharge, up to 28 days ]
    Any adverse events whether related to medication or not



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COVID-19 patients with CT Chest-proven viral pneumonia with any degree of severity.

Exclusion Criteria:

  • Patients < 18 years of age.
  • Patients with mild symptoms (as per WHO criteria) of SARS-CoV-2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394208


Contacts
Layout table for location contacts
Contact: Khaled Salem, MSc +201113451163 ext 6415 khaledsalem@kasralaimy.edu.eg
Contact: Mostafa Alfishawy, Consultant +201550079112 malfishawy@kasralainy.edu.eg

Locations
Layout table for location information
Egypt
Cairo University
Giza, Cairo, Egypt, 12613
Contact: Khaled Salem, MSc    +201113451163    khaledsalem@kasralainy.edu.eg   
Principal Investigator: Khaled Salem, Msc         
Sub-Investigator: Mostafa Alfishawy, MD         
Sponsors and Collaborators
Cairo University
Publications:
Layout table for additonal information
Responsible Party: Khaled Mohammed Korany Salem, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT04394208    
Other Study ID Numbers: CairoU COVID-19 Study Group
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Khaled Mohammed Korany Salem, Cairo University:
COVID-19
SARS-CoV-2
Viral Pneumonia
Drug
Silymarin
Treatment
p38 MAPK Inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs