Covid19Phase 2ReszinateNCT04542993
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
A Phase 2 study testing Zinc Picolinate and Resveratrol in people with Covid19 and SARS-CoV Infection, run by Swedish Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- Zinc Picolinate and Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 5 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment
- Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English
- Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number)
- Willingness to self limit medications and supplements and report what they are taking
- Comfortable self-administering oral medication and nasal swab sampling
- 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.
- Reside within twenty-five miles of one of the Swedish campuses: First Hill, Ballard, Edmonds, Issaquah, Cherry Hill.
Who cannot join
- 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
- Known hypersensitivity to zinc or resveratrol
- Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment
- Preexisting severe pulmonary disease requiring supplemental oxygen
- Clinically evident impairment of cognitive function, per physician discretion
- Active substance abuse that may prevent the subject from completing the protocol requirements, per physician discretion.
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- Active psychotic or affective disorder that may prevent the subject from completing the protocol requirements, per physician discretion.
- Pregnant or lactating females.
- Coumadin treatment that can not be halted during the study period
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- Zinc Picolinate, Resveratrol, Zinc Picolinate Placebo, Resveratrol Placebo
- Keywords
- covid19, SARS-CoV-2, zinc, resveratrol
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc PicolinateDietary supplement
Zinc Picolinate (50 mg PO TID x 5 days)
ResveratrolDietary supplement
Resveratrol 2 grams po BID x 5 days
Zinc Picolinate PlaceboDietary supplement
Zinc Picolinate Matched Placebo PO TID x 5 days
Resveratrol PlaceboDietary supplement
Resveratrol Matched Placebo PO BID x 5 days
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol and Zinc Picolinate combination therapy | Active comparator | Resveratrol and Zinc Picolinate combination therapy Receives: Dietary Supplement: Zinc Picolinate; Dietary Supplement: Resveratrol |
| Resveratrol Placebo and Zinc Placebo combination therapy | Placebo comparator | Placebo Resveratrol and Placebo Zinc combination therapy Receives: Dietary Supplement: Zinc Picolinate Placebo; Dietary Supplement: Resveratrol Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in SARS-CoV-2 Viral load
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
Measured: 1 year
Reduction in Severity of COVID-19 Disease
Review of healthcare resource utilization during study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start8 Sep 2020
- Primary completion5 Feb 2021
- Study completion5 Feb 2021
Why it stopped: Difficulty accruing patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Placebo controlled Resveratrol and Zinc combination therapy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hank Kaplan, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542993
- Sponsor's protocol ID
- SHS KAPH NSWE 20090
- Acronym
- Reszinate
- Status last verified
- Jul 2022
- First submitted
- 8 Sep 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04542993
- Acronym / sponsor ID
- Reszinate / SHS KAPH NSWE 20090
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- covid19, SARS-CoV-2, zinc, resveratrol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing patients
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Placebo controlled Resveratrol and Zinc combination therapy
| Arm | Type | Receives |
|---|---|---|
| Resveratrol and Zinc Picolinate combination therapy | Active comparator | Dietary Supplement: Zinc Picolinate, Dietary Supplement: ResveratrolResveratrol and Zinc Picolinate combination therapy |
| Resveratrol Placebo and Zinc Placebo combination therapy | Placebo comparator | Dietary Supplement: Zinc Picolinate Placebo, Dietary Supplement: Resveratrol PlaceboPlacebo Resveratrol and Placebo Zinc combination therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (18 - 75) with a nasal swab confirmed SARS-CoV-2 infection; testing positive within 4 days of enrollment
- Ability to read, understand and provide informed consent (no legally authorized representatives may consent on their behalf) and study assessments in English
- Ability for subject to comply with the requirements of the study (must/will have a valid email address, internet connection and phone number)
- Willingness to self limit medications and supplements and report what they are taking
- Comfortable self-administering oral medication and nasal swab sampling
Key exclusion criteria (9 listed)
- 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
- Known hypersensitivity to zinc or resveratrol
- Diagnosis of COVID-19 or SARS-CoV-2 infection >4 days before enrollment
- Preexisting severe pulmonary disease requiring supplemental oxygen
- Clinically evident impairment of cognitive function, per physician discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc PicolinateZinc Picolinate (50 mg PO TID x 5 days) | Dietary supplement | Resveratrol and Zinc Picolinate combination therapy |
| ResveratrolResveratrol 2 grams po BID x 5 days | Dietary supplement | Resveratrol and Zinc Picolinate combination therapy |
| Zinc Picolinate PlaceboZinc Picolinate Matched Placebo PO TID x 5 days | Dietary supplement | Resveratrol Placebo and Zinc Placebo combination therapy |
| Resveratrol PlaceboResveratrol Matched Placebo PO BID x 5 days | Dietary supplement | Resveratrol Placebo and Zinc Placebo combination therapy |
Primary outcome
Reduction in SARS-CoV-2 Viral load
Time frame: 1 year
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
Reduction in Severity of COVID-19 Disease
Time frame: 1 year
Review of healthcare resource utilization during study period
Results and safety
The study was stopped early (reason given: Difficulty accruing patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No. Currently no plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hank Kaplan, MD principal investigator
Swedish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc Picolinate and Resveratrol in people with Covid19 and SARS-CoV Infection, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty accruing patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in SARS-CoV-2 Viral load (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.