Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy (Reszinate)

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)

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

Study Overview

• Status: Terminated
• Conditions: Covid19; SARS-CoV Infection
• Intervention / Treatment: Dietary supplement: Zinc Picolinate; Dietary supplement: Resveratrol; Dietary supplement: Zinc Picolinate Placebo; Dietary supplement: Resveratrol Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resveratrol and Zinc Picolinate combination therapy	Dietary supplement: Zinc Picolinate; Zinc Picolinate (50 mg PO TID x 5 days); Dietary supplement: Resveratrol; Resveratrol 2 grams po BID x 5 days
Placebo Comparator: Resveratrol Placebo and Zinc Placebo combination therapy; Placebo Resveratrol and Placebo Zinc combination therapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in SARS-CoV-2 Viral load	Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups	1 year
Reduction in Severity of COVID-19 Disease	Review of healthcare resource utilization during study period	1 year

Collaborators and Investigators

• Sponsor: Swedish Medical Center
• Investigators: Principal Investigator: Hank Kaplan, MD, Swedish Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; zinc; covid19; resveratrol
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Resveratrol; Zinc; Picolinic acid
• Other Study ID Numbers: SHS KAPH NSWE 20090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently no plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No