Status:
UNKNOWN
Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers
Lead Sponsor:
MELISA Institute Genomics & Proteomics Research SpA
Collaborating Sponsors:
Universidad Austral
Conditions:
COVID-19
SARS-CoV2
Eligibility:
All Genders
25+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this clinical trial is to determine the efficacy of Previfenon® (EGCG) to prevent COVID-19, enhance systemic immunity, and decrease the frequency and intensity of selected symptoms when...
Detailed Description
Background. Experimental studies have revealed that epigallocatechin-3-galeate (EGCG), a biologically active polyphenol extracted and purified from Camellia Sinensis, may prevent infection by various ...
Eligibility Criteria
Inclusion
- Volunteer healthcare worker with any valid credential of the center
- 25 years old and over
- Not having been diagnosed with COVID-19
- A healthy individual as per investigator's judgment or stating stable non-transmissible chronic disease without hospitalization in the last year, without change of medications or addition of medications to treat chronic illnesses in the last 3 months.
- No pregnancy or breastfeeding
- Female subjects of childbearing potential using an effective family planning method or surgical sterilization or not sexually active during the study
- Do not drink more than 300 ml of tea a day
- Do not take supplements or products containing EGCG during the study
- Being able to set aside time each day to complete the study questionnaires
- Being able to read and understand the informed consent form before the study
Exclusion
- Healthcare worker who does not have a valid credential from the center
- Under 25 years of age
- Having been diagnosed with a positive rtPCR for COVID-19
- History of febrile acute respiratory disease within the previous 12 weeks
- Volunteer with significant alteration from laboratory tests (standard biochemical profile and hemogram) at screening. A significant abnormality will be defined according investigator's medical judgment.
- Women during pregnancy or breastfeeding
- Female subjects of childbearing age who are sexually active during the study who do not use an effective method of family planning or do not have surgical sterilization
- Known allergy to green tea or EGCG
- Known starch allergy
- User of any medication or supplement containing EGCG
- Volunteer using immunosuppressive drugs
- Autoimmune disease (Lupus, Sjögren or another), liver disease
- Anemia requiring treatment
- Having a chronic infectious disease under treatment
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT04446065
Start Date
September 30 2020
End Date
October 30 2021
Last Update
September 9 2020
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