Zinc and Green Tea Extract for Community Respiratory Viral Infections

NCT04898023 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2035652
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Viral Infection

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Recovered From Cold and Flu-like Symptoms

  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)

  7 days of follow-up

Secondary Outcomes (2)

• Number of Patients With Self-reported Adverse Events

  7 days of follow-up

• Number of Patients Who Reported Days of Absence and/or Healthcare Visits

  7 days of follow-up

Study Arms (2)

zinc-green tea extract-ascorbic acid

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

zinc-green tea extract-ascorbic acid DRUG

Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.

zinc-green tea extract-ascorbic acid

Placebo DRUG

Compounded capsules containing microcrystalline cellulose.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Limitations and Caveats

Due to loss of funding this trial was stopped prior to achieving goal enrollment. As such, no conclusions can be drawn from results reported.

Results Point of Contact

• Title: Ryan Camden
• Organization: University of Missouri Healthcare

camdenr@health.missouri.edu

(575) 882-4141

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Medical Officer

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: September 21, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 20, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Locations

US (1)