Back to results

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

Primary Purpose

Covid19, SARS-CoV Infection

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zinc Picolinate

Resveratrol

Zinc Picolinate Placebo

Resveratrol Placebo

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring covid19, SARS-CoV-2, zinc, resveratrol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment
Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English
Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number)
Willingness to self limit medications and supplements and report what they are taking
Comfortable self-administering oral medication and nasal swab sampling
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.
Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard, Edmonds, Issaquah, Cherry Hill.

Exclusion Criteria:

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
Known hypersensitivity to zinc or resveratrol
Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment
Preexisting severe pulmonary disease requiring supplemental oxygen
Clinically evident impairment of cognitive function, per physician discretion
Active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion.
Active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion.
Pregnant or lactating females.
Coumadin treatment that can not be halted during the study period

Sites / Locations

Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol and Zinc Picolinate combination therapy

Resveratrol Placebo and Zinc Placebo combination therapy

Arm Description

Resveratrol and Zinc Picolinate combination therapy

Placebo Resveratrol and Placebo Zinc combination therapy

Outcomes

Primary Outcome Measures

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

Reduction in Severity of COVID-19 Disease

Review of healthcare resource utilization during study period

Secondary Outcome Measures

Full Information

NCT ID

NCT04542993

First Posted

September 8, 2020

Last Updated

July 26, 2022

Sponsor

Swedish Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04542993

Brief Title

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

Acronym

Reszinate

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Difficulty accruing patients

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

February 5, 2021 (Actual)

Study Completion Date

February 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swedish Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV Infection

Keywords

covid19, SARS-CoV-2, zinc, resveratrol

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Placebo controlled Resveratrol and Zinc combination therapy

Masking

Participant

Masking Description

single blinded

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resveratrol and Zinc Picolinate combination therapy

Arm Type

Active Comparator

Arm Description

Resveratrol and Zinc Picolinate combination therapy

Arm Title

Resveratrol Placebo and Zinc Placebo combination therapy

Arm Type

Placebo Comparator

Arm Description

Placebo Resveratrol and Placebo Zinc combination therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc Picolinate

Intervention Description

Zinc Picolinate (50 mg PO TID x 5 days)

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol

Intervention Description

Resveratrol 2 grams po BID x 5 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc Picolinate Placebo

Intervention Description

Zinc Picolinate Matched Placebo PO TID x 5 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Resveratrol Placebo

Intervention Description

Resveratrol Matched Placebo PO BID x 5 days

Primary Outcome Measure Information:

Title

Reduction in SARS-CoV-2 Viral load

Description

Time Frame

1 year

Title

Reduction in Severity of COVID-19 Disease

Description

Review of healthcare resource utilization during study period

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number) Willingness to self limit medications and supplements and report what they are taking Comfortable self-administering oral medication and nasal swab sampling 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. Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard, Edmonds, Issaquah, Cherry Hill. Exclusion Criteria: 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 Known hypersensitivity to zinc or resveratrol Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment Preexisting severe pulmonary disease requiring supplemental oxygen Clinically evident impairment of cognitive function, per physician discretion Active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion. Active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion. Pregnant or lactating females. Coumadin treatment that can not be halted during the study period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hank Kaplan, MD

Organizational Affiliation

Swedish Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Swedish Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Currently no plan to make IPD available

Learn more about this trial

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

We'll reach out to this number within 24 hrs