Official Title
Can SARS-CoV-2 Viral Shedding in COVID-19 Disease be Reduced by Resveratrol-assisted Zinc Ingestion, a Direct Inhibitor of SARS-CoV-2-RNA Polymerase? A Single Blinded Phase II Protocol (Reszinate Trial)
Brief Summary

Administration of Zinc and resveratrol or double placebo for a period of 5 days and will be monitored for a 14 day period in covid-19 positive patients in an outpatient setting

Detailed Description

Research Question: In ambulatory, non-hospitalized patients with SARS-CoV-2 infection, is it
possible to utilize resveratrol as a transporter for zinc treatment as means to minimize
viral load and severity of resulting COVID-19 disease?

60 ambulatory SARS-CoV-2 positive volunteers who will be randomized into one of two treatment
arms to receive either Zinc and resveratrol or double placebo for a period of 5 days and will
be monitored for a 14 day period. It is anticipated to take approximately 20 weeks to accrue
this cohort resulting in an estimated active project period of 22 weeks, although it may take
up to 12 additional weeks to collect all of the data related to COVID-19 admissions in the
cohort.

Terminated
COVID19
SARS-CoV Infection

Dietary Supplement: Zinc Picolinate

Zinc Picolinate (50 mg PO TID x 5 days)

Dietary Supplement: Resveratrol

Resveratrol 2 grams po BID x 5 days

Dietary Supplement: Zinc Picolinate Placebo

Zinc Picolinate Matched Placebo PO TID x 5 days

Dietary Supplement: Resveratrol Placebo

Resveratrol Matched Placebo PO BID x 5 days

Eligibility Criteria

Inclusion Criteria:

1. Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive
within 4 days of enrollment

2. Ability to read, understand and provide informed consent (no legally authorized
representatives may consent on their behalf) and study assessments in English

3. Ability for subject to comply with the requirements of the study (must/will have a
valid email address, internet connection and phone number)

4. Willingness to self limit medications and supplements and report what they are taking

5. Comfortable self-administering oral medication and nasal swab sampling

6. Willingness to permit a review of their medical history and to provide medical data
from their electronic medical record for the period of enrollment (14 days) and until
resolution of Covid-19 related events. Individuals who are not current Swedish
patients will be asked to identify their provider of record and provide access to
specific elements of their electronic health record.

7. Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard,
Edmonds, Issaquah, Cherry Hill.

Exclusion Criteria:

1. Reported history or evidence of impaired liver or kidney function: GFR <30 or
bilirubin >2x ULT or INR > 2x ULT in the absence of anticoagulants

2. Known hypersensitivity to zinc or resveratrol

3. Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment

4. Preexisting severe pulmonary disease requiring supplemental oxygen

5. Clinically evident impairment of cognitive function, per physician discretion

6. Active substance abuse that may prevent the subject from completing the protocol
requirements, per physician discretion.

7. Active psychotic or affective disorder that may prevent the subject from completing
the protocol requirements, per physician discretion.

8. Pregnant or lactating females.

9. Coumadin treatment that can not be halted during the study period

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
United States
Locations

Swedish Medical Center
Seattle, Washington, United States

Hank Kaplan, MD, Principal Investigator
Swedish Medical Center

Swedish Medical Center
NCT Number
Keywords
COVID19
SARS-CoV-2
Zinc
Resveratrol
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome
Zinc
Resveratrol
Picolinic acid