Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers (HERD)
COVID-19, SARS-CoV2
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring clinical trial, chemoprophylaxis, coronavirus, antiviral agents, epigallocatechin-3-gallate
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Previfenon®
Placebo
Participants will receive coded non-transparent bottles of Previfenon®, each containing 90 EGCG capsules (250 mg per capsule plus excipients) The total EGCG dose per patient will be 750 mg/day (3 capsules) for 40 consecutive days as minimum or a maximum variable time between 60 to 70 days. It will be divided into three daily intakes of one capsule of Previfenon® every 8 hours.
Participants will receive coded non-transparent bottles of placebo, each containing 90 starch capsules (250 mg plus excipients) under the same dosage, frequency and duration that Previfenon@ arm.