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

NCT04542993 | Terminated Phase 2

• 1 other identifier: SHS KAPH NSWE 20090
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; SARS-CoV Infection

Keywords

covid19; SARS-CoV-2; zinc; resveratrol

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• Reduction in Severity of COVID-19 Disease

  Review of healthcare resource utilization during study period

  1 year

Study Arms (2)

Resveratrol and Zinc Picolinate combination therapy

ACTIVE COMPARATOR

Resveratrol and Zinc Picolinate combination therapy

Dietary Supplement: Zinc Picolinate; Dietary Supplement: Resveratrol

Resveratrol Placebo and Zinc Placebo combination therapy

PLACEBO COMPARATOR

Placebo Resveratrol and Placebo Zinc combination therapy

Dietary Supplement: Zinc Picolinate Placebo; Dietary Supplement: Resveratrol Placebo

Interventions

Zinc Picolinate DIETARY_SUPPLEMENT

Zinc Picolinate (50 mg PO TID x 5 days)

Resveratrol and Zinc Picolinate combination therapy

Resveratrol DIETARY_SUPPLEMENT

Resveratrol 2 grams po BID x 5 days

Resveratrol and Zinc Picolinate combination therapy

Zinc Picolinate Placebo DIETARY_SUPPLEMENT

Zinc Picolinate Matched Placebo PO TID x 5 days

Resveratrol Placebo and Zinc Placebo combination therapy

Resveratrol Placebo DIETARY_SUPPLEMENT

Resveratrol Matched Placebo PO BID x 5 days

Resveratrol Placebo and Zinc Placebo combination therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Medical Center: lead

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

picolinic acid; Resveratrol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Hank Kaplan, MD

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled Resveratrol and Zinc combination therapy

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 9, 2020
• Study Start: September 8, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)