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

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)

Sponsors

Lead Sponsor: Swedish Medical Center

Source Swedish Medical Center
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.

Overall Status Recruiting
Start Date September 8, 2020
Completion Date June 2022
Primary Completion Date September 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction in SARS-CoV-2 Viral load 1 year
Reduction in Severity of COVID-19 Disease 1 year
Enrollment 60
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Zinc Picolinate

Description: Zinc Picolinate (50 mg PO TID x 5 days)

Arm Group Label: Resveratrol and Zinc Picolinate combination therapy

Intervention Type: Dietary Supplement

Intervention Name: Resveratrol

Description: Resveratrol 2 grams po BID x 5 days

Arm Group Label: Resveratrol and Zinc Picolinate combination therapy

Intervention Type: Dietary Supplement

Intervention Name: Zinc Picolinate Placebo

Description: Zinc Picolinate Matched Placebo PO TID x 5 days

Arm Group Label: Resveratrol Placebo and Zinc Placebo combination therapy

Intervention Type: Dietary Supplement

Intervention Name: Resveratrol Placebo

Description: Resveratrol Matched Placebo PO BID x 5 days

Arm Group Label: Resveratrol Placebo and Zinc Placebo combination therapy

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Chris Nunn, MD Principal Investigator Swedish Medical Center
Overall Contact

Last Name: Cancer Research

Phone: 206-215-3086

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Swedish Medical Center Hank Kaplan, MD 206-998-4664 [email protected] Hank Kaplan, MD Sub-Investigator Chris Nunn, MD Principal Investigator
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Resveratrol and Zinc Picolinate combination therapy

Type: Active Comparator

Description: Resveratrol and Zinc Picolinate combination therapy

Label: Resveratrol Placebo and Zinc Placebo combination therapy

Type: Placebo Comparator

Description: Placebo Resveratrol and Placebo Zinc combination therapy

Acronym Reszinate
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Intervention Model Description: Placebo controlled Resveratrol and Zinc combination therapy

Primary Purpose: Supportive Care

Masking: Single (Participant)

Masking Description: single blinded

Source: ClinicalTrials.gov