Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers

• Status: Not yet recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: All

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 used as pre-exposure chemoprophylaxis to SARS-CoV-2.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MELISA Institute Genomics & Proteomics Research SpA
• Collaborator: Universidad Austral
• Treatments: Epigallocatechin gallate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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