COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04446065

Cristian Vargas, MD

cvargas@melisainstitute.org

2020-06-24

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

- 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

2

MELISA Institute Genomics & Proteomics Research SpA

25

100

None

Health workers

N/A

524

Event of clinical acute respiratory disease with a diagnosis of COVID-19 confirmed with rtPCR

None

Phase 2/Phase 3

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