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Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400890
Recruitment Status : Terminated (Feasibility)
First Posted : May 26, 2020
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Marvin McCreary, MD, Mount Carmel Health System

Brief 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. 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Resveratrol Dietary Supplement: Vitamin D3 Phase 2

Detailed Description:

This randomized placebo-controlled trial is for the outpatient treatment of 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 SARS-CoV2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 12, 2020
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Resveratrol with Vitamin D3
Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
Drug: Resveratrol
Resveratrol vs placebo given for 15 days.
Other Name: Placebo

Dietary Supplement: Vitamin D3
Vitamin D3 100,000 IU given on day one.

Placebo Comparator: Placebo with Vitamin D3
Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1
Dietary Supplement: Vitamin D3
Vitamin D3 100,000 IU given on day one.




Primary Outcome Measures :
  1. Hospitalization rates for COVID-19 [ Time Frame: 21 days from study randomization ]
    Proportion of study participants admitted to the hospital within 21 days of randomization


Secondary Outcome Measures :
  1. ICU Admission Rates [ Time Frame: 21 days from randomization ]
    Proportion of study participants admitted within 21 who subsequently get admitted to the ICU

  2. Invasive Ventilation Rates [ Time Frame: 21 days from randomization ]
    Proportion of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.

  3. Pneumonia [ Time Frame: 21 days from randomization ]
    Proportion of study participants are diagnosed with pneumonia with 21 day of randomization


Other Outcome Measures:
  1. Adverse events [ Time Frame: 60 days from randomization ]
    Diarrhea, nausea, abdominal cramping



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients who test positive for infection with SARS-CoV-2.
  • Age ≥45 years
  • Mild COVID-19 based on 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

Exclusion Criteria:

  • 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 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.
  • Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe COPD or CHF)
  • Currently pregnant
  • Hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400890


Locations
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United States, Ohio
Mt Carmel HealthSystems
Columbus, Ohio, United States, 43213
Sponsors and Collaborators
Marvin McCreary, MD
Investigators
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Principal Investigator: Marvin R McCreary Mount Carmel Health System
Additional Information:
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Responsible Party: Marvin McCreary, MD, Emergency Physician, Mount Carmel Health System
ClinicalTrials.gov Identifier: NCT04400890    
Other Study ID Numbers: McCreary2020
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marvin McCreary, MD, Mount Carmel Health System:
Coronavirus
SARS-CoV-2
COVID
Vitamin D3
Cholecalciferol
Supplement
Polyphenol
Resveratrol
Stilbene
phytoalexin
Additional relevant MeSH terms:
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Vitamin D
Cholecalciferol
Resveratrol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents