Zinc and resveratrol 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
MD Henry G Kaplan, PhD Kai Wang, Kimberly M Reeves, James M Scanlan, MD Christopher C Nunn, BSNMT Douglas A Kieper, PharmD Joshua L Mark, PhD Inyoul Lee, BS Rachel Liu, MD Ruyun Jin, MD, PhD Michael J Bolton, MD, MPH Jason D Goldman
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 nonstatistically 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.
Author contributions: Conceptualization: HGK, CCN, DAK, JMS, JDG. Data Curation: HGK, KW, KMR, JMS, RJ. Analysis: JMS, RJ. Investigation: all authors. Funding: HGK. Methodology: HGK, KW, CCN, JMS, RJ, JDG. Supervision: HGK, JDG. Writing -original draft: HGK. Writing -review and editing: all authors. Final approval of the manuscript: all authors.
Supporting information:
CONSORT checklist Figure 1
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