- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542993
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)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Swedish Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Resveratrol and Zinc Picolinate combination therapy
|
Zinc Picolinate (50 mg PO TID x 5 days)
Resveratrol 2 grams po BID x 5 days
|
Placebo Comparator: Resveratrol Placebo and Zinc Placebo combination therapy
Placebo Resveratrol and Placebo Zinc combination therapy
|
Zinc Picolinate Matched Placebo PO TID x 5 days
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
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
|
1 year
|
Reduction in Severity of COVID-19 Disease
Time Frame: 1 year
|
Review of healthcare resource utilization during study period
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hank Kaplan, MD, Swedish Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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