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

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ClinicalTrials.gov Identifier: NCT04542993
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center

Tracking Information
First Submitted Date  ICMJE September 8, 2020
First Posted Date  ICMJE September 9, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE September 8, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2020)
  • Reduction in SARS-CoV-2 Viral load [ Time Frame: 1 year ]
    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 [ Time Frame: 1 year ]
    Review of healthcare resource utilization during study period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
Official Title  ICMJE 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Placebo controlled Resveratrol and Zinc combination therapy
Masking: Single (Participant)
Masking Description:
single blinded
Primary Purpose: Supportive Care
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Resveratrol and Zinc Picolinate combination therapy
    Resveratrol and Zinc Picolinate combination therapy
    Interventions:
    • Dietary Supplement: Zinc Picolinate
    • Dietary Supplement: Resveratrol
  • Placebo Comparator: Resveratrol Placebo and Zinc Placebo combination therapy
    Placebo Resveratrol and Placebo Zinc combination therapy
    Interventions:
    • Dietary Supplement: Zinc Picolinate Placebo
    • Dietary Supplement: Resveratrol Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cancer Research 206-215-3086 CancerResearch@swedish.org
Contact: Cancer Regulatory CancerRegulatory@swedish.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04542993
Other Study ID Numbers  ICMJE SHS KAPH NSWE 20090
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Currently no plan to make IPD available
Responsible Party Swedish Medical Center
Study Sponsor  ICMJE Swedish Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chris Nunn, MD Swedish Medical Center
PRS Account Swedish Medical Center
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP