Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers

NCT04446065 | Unknown Phase 2 DMC

• 1 other identifier: MEL109042020
• Study Type: interventional
• Target: 524
• Locations: 0 countries
• Sites: N/A

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

Conditions

COVID-19; SARS-CoV2

Keywords

clinical trial; chemoprophylaxis; coronavirus; antiviral agents; epigallocatechin-3-gallate

Outcome Measures

Primary Outcomes (1)

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

  A positive case or event of COVID-19 is defined as a patient with acute respiratory illness presenting fever (37.8º C); at least one of the following symptoms: odynophagia, cough, myalgia, or dyspnea; and a specific positive rtPCR test for SARS-CoV-2.

  The date for censoring a case will be defined as that date when the rtPCR test results positive minus 4 days, with the aim to calculate the time free of clinically defined COVID-19 infection over 40 to 70 days of intervention

Secondary Outcomes (4)

• Rate of positive cases for IgM and IgG anti-SARS-CoV-2

  Positive cases in each two-week examination and to the end of the study over 40 to 70 days of intervention

• Composite outcome considering symptomatic and asymptomatic cases with positive rtPCR test

  Positive cases in each two-weeks examination and to the end of the study over 40 to 70 days of intervention

• Hospitalization due to any acute respiratory infection

  Positive cases in each two-week examination visit and to the end of the study over 40 to 70 days of intervention

• Event of upper and lower airway respiratory infection

  Positive cases in each two-week examination and to the end of the study over 40 to 70 days of intervention

Other Outcomes (4)

• Exploratory outcome: Frequency and intensity of selected symptoms for COVID-19

  Different VAS scores calculated each two-week examination visit over 40 to 70 days of intervention

• Primary safety outcome: event of major hepatic harm

  Cases accounted by liver profile lab test in each two-week examination visit over 40 to 70 days of intervention.

• Event of liver enzymes over 3 times the normal value

  Cases accounted by liver profile lab test in each two-week examination visit over 40 to 70 days of intervention

Study Arms (2)

Previfenon®

EXPERIMENTAL

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.

Drug: Previfenon®

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Previfenon® DRUG

Every capsule of Previfenon® (patent pending) provides 250 mg EGCG ≥ 98% purity with a carefully selected set of excipients to improve flowability, stabilize EGCG against early auto-oxidation, and increase its hepatoprotective activity with prolonged use.

Also known as: Epigallocatechin-3-Gallate, EGCG

Previfenon®

Placebo DRUG

Participants will receive placebo starch capsules (250 mg plus excipients) identical in appearance and taste to Previfenon® capsules in a double-blind manner.

Also known as: Starch

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer healthcare worker with any valid credential of the center
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MELISA Institute Genomics & Proteomics Research SpA: lead
• Universidad Austral: collaborator

Related Links

• MELISA Institute

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

epigallocatechin gallate; Starch

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Elard S Koch, PhD

  MELISA Institute Genomics & Proteomics Research SpA

  STUDY DIRECTOR

Central Study Contacts

Cristian Vargas, MD

CONTACT

+56412467242; cvargas@melisainstitute.org

Miguel A Bravo, MPH

CONTACT

+56412467242; mbravo@melisainstitute.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Reserach

Model Details: The study will use 2 parallel groups in each center to compare the effects of an oral formulation of EGCG (Previfenon®, patent pending) with those of placebo (starch) in the prevention of respiratory disease caused by SARS-CoV-2 (COVID-19) in health care workers directly exposed to clinical care, daily contact, or traffic of individuals with suspected for COVID-19 during the epidemic outbreak.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 24, 2020
• Study Start: September 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 30, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP