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

Covid19 Clinical Trial

— Reszinate  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04542993
• Other study ID #: SHS KAPH NSWE 20090
• Status: Terminated
• Phase: Phase 2
• Start date: September 8, 2020
• Est. completion date: February 5, 2021

Study information

• Verified date: July 2022
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: February 5, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Dietary Supplement:
• Zinc Picolinate
Zinc Picolinate (50 mg PO TID x 5 days)
• Resveratrol
Resveratrol 2 grams po BID x 5 days
• Zinc Picolinate Placebo
Zinc Picolinate Matched Placebo PO TID x 5 days
• Resveratrol Placebo
Resveratrol Matched Placebo PO BID x 5 days

Locations

Country	Name	City	State
United States	Swedish Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reduction in Severity of COVID-19 Disease	Review of healthcare resource utilization during study period	1 year