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

Phase 2

Terminated

• Conditions: Covid19; SARS-CoV Infection
• Interventions: Dietary Supplement: Zinc Picolinate Placebo; Dietary Supplement: Zinc Picolinate; Dietary Supplement: Resveratrol Placebo; Dietary Supplement: Resveratrol

• Registration Number: NCT04542993
• Lead Sponsor: 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

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 Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resveratrol Placebo and Zinc Placebo combination therapy	Zinc Picolinate Placebo	Placebo Resveratrol and Placebo Zinc combination therapy
Resveratrol Placebo and Zinc Placebo combination therapy	Resveratrol Placebo	Placebo Resveratrol and Placebo Zinc combination therapy
Resveratrol and Zinc Picolinate combination therapy	Resveratrol	Resveratrol and Zinc Picolinate combination therapy
Resveratrol and Zinc Picolinate combination therapy	Zinc Picolinate	Resveratrol and Zinc Picolinate combination therapy

Primary Outcome Measures

Name	Time	Method
Reduction in Severity of COVID-19 Disease	1 year	Review of healthcare resource utilization during study period
Reduction in SARS-CoV-2 Viral load	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

Trial Locations

Locations (1)

Swedish Medical Center; 🇺🇸 Seattle, Washington, United States