Respiratory Viral Infection
Conditions
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.
Interventions
DRUGzinc-green tea extract-ascorbic acid
Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid.
DRUGPlacebo
Compounded capsules containing microcrystalline cellulose.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 years and older 4. Ability to take oral medication and be willing to adhere to the prescribed dosing regimen 5. Self-reported cold or flu symptoms for \< 72 hours
Exclusion criteria
1. Pregnant or actively seeking to become pregnant 2. Positive for influenza with planned treatment with oseltamivir or baloxavir 3. Current or planned treatment with an FDA regulated drug (including those under EUA) for COVID-19 4. Chronic liver disease (i.e. baseline liver function tests (LFTs) \> 1.5x the upper limit of normal (ULN) or established cirrhosis 5. Chronic renal failure stage 4 or greater 6. History of kidney stones 7. Acute secondary bacterial infection at the time of enrollment 8. Requiring hospitalization for any reason at the time of enrollment 9. History of copper or iron deficiency 10. Current prescription for quinolone antibiotics, tetracycline antibiotics, or penicillamine at the time of enrollment 11. Allergy/intolerance to any of the active ingredients under investigation including zinc citrate, green tea, and ascorbic acid (vitamin C) 12. Patients without decision making capacity 13. Currently enrolled in another clinical trial for a respiratory viral infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
17 patients signed consent forms, but only 14 completed at least one study visit for which efficacy and safety endpoints could be assessed.
Participants by arm
| Arm | Count |
|---|---|
| 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.
zinc-green tea extract-ascorbic acid: Compounded capsules containing each zinc citrate, green tea extract, and ascorbic acid. | 5 |
| 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.
Placebo: Compounded capsules containing microcrystalline cellulose. | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Zinc-green Tea Extract-ascorbic Acid | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 19.4 years | 23.6 years | 21.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 2 / 5 | 3 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
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)
Time frame: 7 days of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinc-green Tea Extract-ascorbic Acid | Number of Patients Who Recovered From Cold and Flu-like Symptoms | 3 Participants |
| Placebo | Number of Patients Who Recovered From Cold and Flu-like Symptoms | 4 Participants |
Secondary
Number of Patients Who Reported Days of Absence and/or Healthcare Visits
Absence includes missed days from work or school and healthcare visits include hospitalization or physician office visit(s) for respiratory viral illness related complications
Time frame: 7 days of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinc-green Tea Extract-ascorbic Acid | Number of Patients Who Reported Days of Absence and/or Healthcare Visits | 5 Participants |
| Placebo | Number of Patients Who Reported Days of Absence and/or Healthcare Visits | 3 Participants |
Secondary
Number of Patients With Self-reported Adverse Events
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
Time frame: 7 days of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zinc-green Tea Extract-ascorbic Acid | Number of Patients With Self-reported Adverse Events | 2 Participants |
| Placebo | Number of Patients With Self-reported Adverse Events | 3 Participants |