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Resveratrol and Zinc in the Treatment of Outpatients With COVID-19 – The Reszinate Study - A Phase 1/2 Randomized Clinical Trial Utilizing Home Patient-Obtained Nasal and Saliva Viral Sampling

40 Pages Posted: 1 Oct 2021

See all articles by Henry G. Kaplan

Henry G. Kaplan

Swedish Medical Center - Swedish Cancer Institute

Kai Wang

Institute for Systems Biology

Kimberly M. Reeves

Swedish Medical Center - Swedish Cancer Institute

James M. Scanlan

Swedish Medical Center - Swedish Cancer Institute

Christopher C. Nunn

Swedish Medical Center - Department of Anesthesiology

Douglas A. Kieper

Swedish Medical Center - Swedish Cancer Institute

Joshua L. Mark

Swedish Medical Center - Swedish Cancer Institute

Inyoul Lee

Institute for Systems Biology

Rachel Liu

Institute for Systems Biology

Ruyun Jin

Providence Research Network - Center for Cardiovascular Analytics

Michael J. Bolton

Swedish Medical Center - Division of Infectious Diseases

Jason Goldman

Swedish Medical Group, Providence St Joseph Health; Division of Allergy and Infectious Diseases

More...

Abstract

Background: Safe, effective, inexpensive treatment for COVID-19 is an urgent unmet medical need. Zinc and resveratrol have been reported to have antiviral activity and resveratrol may increase zinc activity at the site of replication by increasing intracellular zinc concentrations.

Methods: A 1:1 randomized, placebo-controlled trial of zinc 150 mg plus resveratrol 4 grams daily for 5 days versus placebos in SARS-CoV-2 positive outpatients was carried out 9/21/2020 – 1/22/2021 in Seattle, Washington. Patients were enrolled within four days of testing positive if they had no chronic liver, kidney, or lung disease and did not have hypoxia requiring supplemental oxygen. Viral shedding was followed at days 1-7,10, and 14 with patient self-collected nasal and saliva samples by measuring qRT-PCR for SARS-CoV-2 N gene. Patients filled out a web-based questionnaire on days 1-14 to report symptoms, vital signs and adherence to study intervention.

Findings: 45 persons consented to enrollment, and 30 (14 treatment; 16 placebo) had ≥1 day of the protocol treatment and were evaluable for the primary or secondary outcome. There was no difference in viral shedding between groups. There was a non-statistically significant trend toward more rapid decrease in symptoms in the treatment group. Viral shedding was similar between patient self-collected mid-turbinate nasal swabs and expectorated saliva samples with good correlation, R= 0.67, p<0.001.

Interpretation: SARS-CoV-2 shedding and COVID-19 symptoms were not statistically significantly decreased by treatment in this small Phase 1/2 pilot study. Viral shedding correlates well between patient-obtained home nasal swab and saliva sampling.

Clinical Trial Registration Details: Clinical Trials.gov NCT04542993

Funding Information: This study was funded by the Kaplan Cancer Research Fund.

Declaration of Interests: JDG reports research support from Lilly, Gilead, and Regeneron; grants from the NIH, BARDA (administered by Merck) and Viracor to his institution; and speaker or consulting personal fees from Lilly, Gilead, and Mylan. All other authors report no conflicts of interest.

Ethics Approval Statement: The study was approved by the Providence St Joseph Health Care System IRB. Informed consent was obtained with electronic consent forms by the principal investigator.

Keywords: COVID-19, zinc, resveratrol, saliva, SARS-CoV-2

Suggested Citation

Kaplan, Henry G. and Wang, Kai and Reeves, Kimberly M. and Scanlan, James M. and Nunn, Christopher C. and Kieper, Douglas A. and Mark, Joshua L. and Lee, Inyoul and Liu, Rachel and Jin, Ruyun and Bolton, Michael J. and Goldman, Jason, Resveratrol and Zinc in the Treatment of Outpatients With COVID-19 – The Reszinate Study - A Phase 1/2 Randomized Clinical Trial Utilizing Home Patient-Obtained Nasal and Saliva Viral Sampling. Available at SSRN: https://ssrn.com/abstract=3934228 or http://dx.doi.org/10.2139/ssrn.3934228

Henry G. Kaplan (Contact Author)

Swedish Medical Center - Swedish Cancer Institute ( email )

Seattle, WA 98104
United States

Kai Wang

Institute for Systems Biology

401 Terry Ave N.
Seattle, WA 98109
United States

Kimberly M. Reeves

Swedish Medical Center - Swedish Cancer Institute ( email )

Seattle, WA 98104
United States

James M. Scanlan

Swedish Medical Center - Swedish Cancer Institute ( email )

Seattle, WA 98104
United States

Christopher C. Nunn

Swedish Medical Center - Department of Anesthesiology ( email )

United States

Douglas A. Kieper

Swedish Medical Center - Swedish Cancer Institute ( email )

Seattle, WA 98104
United States

Joshua L. Mark

Swedish Medical Center - Swedish Cancer Institute ( email )

Seattle, WA 98104
United States

Inyoul Lee

Institute for Systems Biology

401 Terry Ave N.
Seattle, WA 98109
United States

Rachel Liu

Institute for Systems Biology

401 Terry Ave N.
Seattle, WA 98109
United States

Ruyun Jin

Providence Research Network - Center for Cardiovascular Analytics ( email )

United States

Michael J. Bolton

Swedish Medical Center - Division of Infectious Diseases ( email )

United States

Jason Goldman

Swedish Medical Group, Providence St Joseph Health ( email )

1124 Columbia St. STE 600
Seattle, WA 98104
United States

Division of Allergy and Infectious Diseases ( email )

Seattle, WA 98195
United States

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