Clinical trial NCT04542993: Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
SARS-CoV Infection
Keywords: covid19
SARS-CoV-2
zinc
resveratrol
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Placebo controlled Resveratrol and Zinc combination therapy
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Reduction in SARS-CoV-2 Viral load
timeFrame: 1 year
measure: Reduction in Severity of COVID-19 Disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Hank Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: