Zinc and Green Tea Extract for Community Respiratory Viral Infections

Study Overview
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Brief Summary
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Zinc and green tea supplementation have both been independently studied for supporting immune health during cold and flu-like illness in non-hospitalized patients with clinical trials demonstrating promising but inconsistent results. Combination therapy may offer an improved effect as the antioxidant compounds found in green tea have been shown to increase cellular zinc concentrations thereby inhibiting viral replication. This study seeks to evaluate the effect of combination supplementation using established doses of zinc and green tea extract on symptom duration and severity from cold and flu-like illness, including COVID-19, in adult community patients enrolled in a randomized placebo-controlled trial.

Official Title
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Evaluation of Combination Zinc and Green Tea Extract Supplementation on Reduction in Symptom Duration and Severity Associated With Community Respiratory Viral Infections: a Randomized Control Trial (ZiPhenol Study)

Conditions
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Respiratory Viral Infection

Intervention / Treatment
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* Drug: zinc-green tea extract-ascorbic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 18 years and older Ability to take oral medication and be willing to adhere to the prescribed dosing regimen Self-reported cold or flu symptoms for < 72 hours Exclusion Criteria: Pregnant or actively seeking to become pregnant Positive for influenza with planned treatment with oseltamivir or baloxavir Current or planned treatment with an FDA regulated drug (including those under EUA) for COVID-19 Chronic liver disease (i.e. baseline liver function tests (LFTs) > 1.5x the upper limit of normal (ULN) or established cirrhosis Chronic renal failure stage 4 or greater History of kidney stones Acute secondary bacterial infection at the time of enrollment Requiring hospitalization for any reason at the time of enrollment History of copper or iron deficiency Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C) Patients without decision making capacity Currently enrolled in another clinical trial for a respiratory viral infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zinc-green tea extract-ascorbic acid<br>Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. | Drug: zinc-green tea extract-ascorbic acid<br>* Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.<br>|
| Placebo Comparator: Placebo<br>Randomized patients will take three (3) capsules taken orally two (2) hours following a meal twice daily x5 days and be blinded to study assignment. | Drug: Placebo<br>* Compounded capsules containing microcrystalline cellulose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recovery from cold and flu-like symptoms | Rate of recovery is defined as achieving a daily total symptom severity score of 0 or 1 within 7 days using an established 12 symptom scoring system with a severity scale ranging from 0-absent to 3-very severe for each symptom (max of 36 points) | 7 days of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of patient-reported adverse events | Adverse events to be collected include: nausea, vomiting, indigestion, worsening of shortness of breath or difficulty breathing, allergic reaction including skin rash, and need to seek medical care (e.g. hospitalization or physician visit) for a suspected study drug related adverse effect | 7 days of follow-up | 
| Rates of patient-reported days of absence and/or healthcare visits | Absence will include missed days from work or school and healthcare visits will include hospitalization or physician office visit(s) for respiratory viral illness related complications | 7 days of follow-up |