Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542993
Status:
TERMINATED
Last Update Posted:
2022-07-29
First Post:
2020-09-08
Brief Title:
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
Sponsor:
Swedish Medical Center
Organization:
Swedish Medical Center
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty accruing patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reszinate
Brief Summary:
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
Detailed Description:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None