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Protection of Health Workers Against COVID-19 (HERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04446065
Recruitment Status : Not yet recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Universidad Austral
Information provided by (Responsible Party):
Elard Koch, PhD, MELISA Institute Genomics & Proteomics Research SpA

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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV2 Drug: Previfenon® Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Trial to Protect Health Workers Against COVID-19 by Using Previfenon® as Chemoprophylaxis During a SARS-CoV-2 Outbreak. The HERD Study
Estimated Study Start Date : July 30, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: Previfenon®
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®
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.
Other Name: Epigallocatechin-3-Gallate, EGCG

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




Primary Outcome Measures :
  1. Event of clinical acute respiratory disease with a diagnosis of COVID-19 confirmed with rtPCR [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Rate of positive cases for IgM and IgG anti-SARS-CoV-2 [ Time Frame: Positive cases in each two-week examination and to the end of the study over 40 to 70 days of intervention ]
    Rate of positive cases for IgM and IgG anti-SARS-CoV-2 measured by immunochromatographic test in treatment and placebo group at the end of the study

  2. Composite outcome considering symptomatic and asymptomatic cases with positive rtPCR test [ Time Frame: Positive cases in each two-weeks examination and to the end of the study over 40 to 70 days of intervention ]
    Rate of asymptomatic cases defined as a positive rtPCR for SARS-CoV-2 viral RNA but with no symptoms of COVID-19 in treatment and placebo group at the end of the study, and a composite outcome considering symptomatic and asymptomatic cases (i.e. all cases with positive rtPCR test)

  3. Hospitalization due to any acute respiratory infection [ Time Frame: Positive cases in each two-week examination visit and to the end of the study over 40 to 70 days of intervention ]
    Rate of hospitalizations due to any acute respiratory infection at the end of the study

  4. Event of upper and lower airway respiratory infection [ Time Frame: Positive cases in each two-week examination and to the end of the study over 40 to 70 days of intervention ]
    Global frequency of events of upper and lower airway respiratory infections


Other Outcome Measures:
  1. Exploratory outcome: Frequency and intensity of selected symptoms for COVID-19 [ Time Frame: Different VAS scores calculated each two-week examination visit over 40 to 70 days of intervention ]
    Registry of Visual Analogue Scale (VAS) in the log diary of every healthcare worker for the following selected symptoms: cough, muscle pain (myalgia); difficulty breathing (dyspnea); loss of smell (anosmia); loss of taste (ageusia); pain when swallowing (odynophagia, sore throat); and finally headache

  2. Primary safety outcome: event of major hepatic harm [ Time Frame: Cases accounted by liver profile lab test in each two-week examination visit over 40 to 70 days of intervention. ]
    Elevation of liver enzymes over 5 times the normal value

  3. Event of liver enzymes over 3 times the normal value [ Time Frame: Cases accounted by liver profile lab test in each two-week examination visit over 40 to 70 days of intervention ]
    Elevation of liver enzymes over 5 times the normal value

  4. Frequency of adverse events [ Time Frame: Records of self-reported adverse effects on log dairy accounted in each examination visit over 40 to 70 days of intervention ]
    Any adverse event reported over the intervention period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446065


Contacts
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Contact: Cristian Vargas, MD +56412467242 cvargas@melisainstitute.org
Contact: Miguel A Bravo, MPH +56412467242 mbravo@melisainstitute.org

Sponsors and Collaborators
MELISA Institute Genomics & Proteomics Research SpA
Universidad Austral
Investigators
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Study Director: Elard S Koch, PhD MELISA Institute Genomics & Proteomics Research SpA
Additional Information:
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Responsible Party: Elard Koch, PhD, Head of Reserach, MELISA Institute Genomics & Proteomics Research SpA
ClinicalTrials.gov Identifier: NCT04446065    
Other Study ID Numbers: MEL109042020
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results of this study will be published as open access article and all IPD that underlie results in a publication will be shared, preferentially as supplementary data set or available in a public repository. Any sensitive personal data/information will be not included.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elard Koch, PhD, MELISA Institute Genomics & Proteomics Research SpA:
clinical trial
chemoprophylaxis
coronavirus
antiviral agents
epigallocatechin-3-gallate
Additional relevant MeSH terms:
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Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents