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
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV2||Drug: Previfenon® Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||524 participants|
|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)|
|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|
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.
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.
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
- 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.
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
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
|Contact: Cristian Vargas, MDfirstname.lastname@example.org|
|Contact: Miguel A Bravo, MPHemail@example.com|
|Study Director:||Elard S Koch, PhD||MELISA Institute Genomics & Proteomics Research SpA|