Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
NCT ID: NCT04542993
Last Updated: 2022-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
45 participants
INTERVENTIONAL
2020-09-08
2021-02-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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Resveratrol and Zinc Picolinate combination therapy
Resveratrol and Zinc Picolinate combination therapy
Zinc Picolinate
Zinc Picolinate (50 mg PO TID x 5 days)
Resveratrol
Resveratrol 2 grams po BID x 5 days
Resveratrol Placebo and Zinc Placebo combination therapy
Placebo Resveratrol and Placebo Zinc combination therapy
Zinc Picolinate Placebo
Zinc Picolinate Matched Placebo PO TID x 5 days
Resveratrol Placebo
Resveratrol Matched Placebo PO BID x 5 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Swedish Medical Center
OTHER
Responsible Party
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Principal Investigators
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Hank Kaplan, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Locations
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Swedish Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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SHS KAPH NSWE 20090
Identifier Type: -
Identifier Source: org_study_id
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