COVID-19Phase 2NCT04400890
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
A Phase 2 study testing Resveratrol and Vitamin D3 in people with COVID-19, run by Marvin McCreary, MD at 1 site in United States.
Trial summary
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Resveratrol and Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2020to 1 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who test positive for infection with SARS-CoV-2.
- Age ≥45 years
- Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
- Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.
- Patient must have access to the internet or a smartphone to complete surveys.
- English-speaking patients
Who cannot join
- Diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician
- Asymptomatic patients (e.g. patients who were screened without symptoms but tested positive)
- Known or suspected liver disease or Hepatitis C
- Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60
- Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window.
- Allergy to grapes or rice.
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- Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF))
- Currently pregnant
- Hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
Read the detailed description
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.
200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.
- Conditions
- COVID-19
- Being tested
- Resveratrol, Vitamin D3
- Keywords
- Coronavirus, SARS-CoV-2, COVID, Vitamin D3, Cholecalciferol, Supplement, Polyphenol, Resveratrol, Stilbene, phytoalexin
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Placebo
Resveratrol vs placebo given for 15 days.
Vitamin D3Dietary supplement
Vitamin D3 100,000 IU given on day one.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol with Vitamin D3 | Active comparator | Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1 Receives: Drug: Resveratrol; Dietary Supplement: Vitamin D3 |
| Placebo with Vitamin D3 | Placebo comparator | Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1 Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Rates for COVID-19
Number of study participants admitted to the hospital within 21 days of randomization
Measured: 21 days from study randomization
Secondary outcomes (5)
ICU Admission Rates
Number of study participants admitted within 21 who subsequently get admitted to the ICU
Measured: 21 days from randomization
Invasive Ventilation Rates
Number of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.
Measured: 21 days from randomization
Pneumonia
Number of study participants are diagnosed with pneumonia with 21 day of randomization
Measured: 21 days from randomization
Pulmonary Embolism
Number of study participants are diagnosed with pulmonary embolism with 21 day of randomization
Measured: 21 days from start of randomization.
Death
Number of study participants who died with 21 day of randomization
Measured: Within 21 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start13 Sep 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marvin McCreary, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marvin McCreary, MD, Mount Carmel Health System
- Investigators
- Marvin R McCreary, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400890
- Sponsor's protocol ID
- McCreary2020
- Status last verified
- Feb 2023
- First submitted
- 22 May 2020
- Last updated
- 24 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
McCreary MR, Schnell PM, Rhoda DA. Randomized double-blind placebo-controlled proof-of-concept trial of resveratrol for outpatient treatment of mild coronavirus disease (COVID-19). Sci Rep. 2022 Jun 29;12(1):10978. doi: 10.1038/s41598-022-13920-9.
PubMed 35768453McCreary MR, Schnell PM, Rhoda DA. Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19). Res Sq [Preprint]. 2021 Sep 13:rs.3.rs-861831. doi: 10.21203/rs.3.rs-861831/v1.
PubMed 34545357
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04400890
- Acronym / sponsor ID
- McCreary2020
- Conditions
- COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, COVID, Vitamin D3, Cholecalciferol, Supplement, Polyphenol, Resveratrol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Marvin McCreary, MDUniversity, hospital or other
- Study start
- 13 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Posted 24 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
Detailed description
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.
200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol with Vitamin D3 | Active comparator | Drug: Resveratrol, Dietary Supplement: Vitamin D3Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1 |
| Placebo with Vitamin D3 | Placebo comparator | Dietary Supplement: Vitamin D3Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients who test positive for infection with SARS-CoV-2.
- Age ≥45 years
- Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
- Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.
- Patient must have access to the internet or a smartphone to complete surveys.
Key exclusion criteria (9 listed)
- Diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician
- Asymptomatic patients (e.g. patients who were screened without symptoms but tested positive)
- Known or suspected liver disease or Hepatitis C
- Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60
- Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window.
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 |
|---|---|---|
| ResveratrolAlso: PlaceboResveratrol vs placebo given for 15 days. | Drug | Resveratrol with Vitamin D3 |
| Vitamin D3Vitamin D3 100,000 IU given on day one. | Dietary supplement | Placebo with Vitamin D3, Resveratrol with Vitamin D3 |
Primary outcome
Hospitalization Rates for COVID-19
Time frame: 21 days from study randomization
Number of study participants admitted to the hospital within 21 days of randomization
5 secondary outcomes
ICU Admission Rates
Time frame: 21 days from randomization
Invasive Ventilation Rates
Time frame: 21 days from randomization
Pneumonia
Time frame: 21 days from randomization
Pulmonary Embolism
Time frame: 21 days from start of randomization.
Death
Time frame: Within 21 days from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35768453McCreary MR, Schnell PM, Rhoda DA. Randomized double-blind placebo-controlled proof-of-concept trial of resveratrol for outpatient treatment of mild coronavirus disease (COVID-19). Sci Rep. 2022 Jun 29;12(1):10978. doi: 10.1038/s41598-022-13920-9.
- Derived from this study: PubMed 34545357McCreary MR, Schnell PM, Rhoda DA. Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19). Res Sq [Preprint]. 2021 Sep 13:rs.3.rs-861831. doi: 10.21203/rs.3.rs-861831/v1.
- Peer reviewed final publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Marvin R McCreary principal investigator
Mount Carmel Health System
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 Resveratrol and Vitamin D3 in people with COVID-19, run by Marvin McCreary, MD 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 6 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 24 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospitalization Rates for COVID-19 (time frame: 21 days from study randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04400890, which also lists 2 linked publications.
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 24 Feb 2023.