Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
Study NCT ID:
NCT04542993
Status:
TERMINATED
Last Update Posted:
2022-07-29
First Post:
2020-09-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030614', 'term': 'picolinic acid'}, {'id': 'D000077185', 'term': 'Resveratrol'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blinded'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Placebo controlled Resveratrol and Zinc combination therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'whyStopped': 'Difficulty accruing patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in SARS-CoV-2 Viral load', 'timeFrame': '1 year', 'description': 'Viral AUCs normalized to peak viral load and housekeeper genes will be calculated, the AUCs on subjects with complete data will be used as dependent measures in t-tests, regressions and repeated measures mixed ANOVAs to compare viral load reduction between groups'}, {'measure': 'Reduction in Severity of COVID-19 Disease', 'timeFrame': '1 year', 'description': 'Review of healthcare resource utilization during study period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid19', 'SARS-CoV-2', 'zinc', 'resveratrol'], 'conditions': ['Covid19', 'SARS-CoV Infection']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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?\n\n60 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment\n2. Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English\n3. Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number)\n4. Willingness to self limit medications and supplements and report what they are taking\n5. Comfortable self-administering oral medication and nasal swab sampling\n6. 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.\n7. Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard, Edmonds, Issaquah, Cherry Hill.\n\nExclusion Criteria:\n\n1. 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\n2. Known hypersensitivity to zinc or resveratrol\n3. Diagnosis of COVID-19 or SARS-CoV-2 infection \\>4 days before enrollment\n4. Preexisting severe pulmonary disease requiring supplemental oxygen\n5. Clinically evident impairment of cognitive function, per physician discretion\n6. Active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion.\n7. Active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion.\n8. Pregnant or lactating females.\n9. Coumadin treatment that can not be halted during the study period'}, 'identificationModule': {'nctId': 'NCT04542993', 'acronym': 'Reszinate', 'briefTitle': 'Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Medical Center'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'SHS KAPH NSWE 20090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Resveratrol and Zinc Picolinate combination therapy', 'description': 'Resveratrol and Zinc Picolinate combination therapy', 'interventionNames': ['Dietary Supplement: Zinc Picolinate', 'Dietary Supplement: Resveratrol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Resveratrol Placebo and Zinc Placebo combination therapy', 'description': 'Placebo Resveratrol and Placebo Zinc combination therapy', 'interventionNames': ['Dietary Supplement: Zinc Picolinate Placebo', 'Dietary Supplement: Resveratrol Placebo']}], 'interventions': [{'name': 'Zinc Picolinate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc Picolinate (50 mg PO TID x 5 days)', 'armGroupLabels': ['Resveratrol and Zinc Picolinate combination therapy']}, {'name': 'Resveratrol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Resveratrol 2 grams po BID x 5 days', 'armGroupLabels': ['Resveratrol and Zinc Picolinate combination therapy']}, {'name': 'Zinc Picolinate Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc Picolinate Matched Placebo PO TID x 5 days', 'armGroupLabels': ['Resveratrol Placebo and Zinc Placebo combination therapy']}, {'name': 'Resveratrol Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Resveratrol Matched Placebo PO BID x 5 days', 'armGroupLabels': ['Resveratrol Placebo and Zinc Placebo combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Hank Kaplan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently no plan to make IPD available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}