Zinc and Green Tea Extract for Community Respiratory Viral Infections

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
zinc-green tea extract-ascorbic acid	zinc-green tea extract-ascorbic acid	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Recovered From Cold and Flu-like Symptoms	7 days of follow-up	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 score ranging from 0-absent to 3-very severe for each symptom assessed (max of 36 points possible; higher scores indicate a greater severity of symptoms)

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Self-reported Adverse Events	7 days of follow-up	Adverse events 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
Number of Patients Who Reported Days of Absence and/or Healthcare Visits	7 days of follow-up	Absence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications