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

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.<br><br>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.<br><br>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.<br><br>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.<br><br>Clinical Trial Registration Details: Clinical Trials.gov NCT04542993<br><br>Funding Information: This study was funded by the Kaplan Cancer Research Fund.<br><br>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.<br><br>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.