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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

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

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Dietary Supplement: Zinc Picolinate Dietary Supplement: Resveratrol Dietary Supplement: Zinc Picolinate Placebo Dietary Supplement: Resveratrol Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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)
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Active Comparator: Resveratrol and Zinc Picolinate combination therapy
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




Primary Outcome Measures :
  1. 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

  2. Reduction in Severity of COVID-19 Disease [ Time Frame: 1 year ]
    Review of healthcare resource utilization during study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04542993


Contacts
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Contact: Cancer Research 206-215-3086 CancerResearch@swedish.org
Contact: Cancer Regulatory CancerRegulatory@swedish.org

Locations
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United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Hank Kaplan, MD    206-998-4664    Research.Center@Swedish.org   
Sub-Investigator: Hank Kaplan, MD         
Principal Investigator: Chris Nunn, MD         
Sponsors and Collaborators
Swedish Medical Center
Investigators
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Principal Investigator: Chris Nunn, MD Swedish Medical Center
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Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT04542993    
Other Study ID Numbers: SHS KAPH NSWE 20090
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently no plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swedish Medical Center:
covid19
SARS-CoV-2
zinc
resveratrol
Additional relevant MeSH terms:
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Zinc
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Resveratrol
Picolinic acid
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors