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Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400890
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Marvin McCreary, MD, Mount Carmel Health System

Brief Summary:
There is evidence that resveratrol 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 resveratrol and explore effectiveness.

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

Detailed Description:
200 subjects (100 receiving resveratrol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take the treatment 4 times a day for 15 days, plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Resveratrol with Vitamin D3
Resveratrol 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 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 testing positive from COVID-19 ]
    Proportion of study participants admitted to the hospital within 21 days of testing positive


Secondary Outcome Measures :
  1. ICU Admission Rates [ Time Frame: 21 days from testing positive from COVID-19 ]
    Proportion of study participants admitted to the ICU within 21 days of testing positive

  2. Invasive Ventilation Rates [ Time Frame: 21 days from testing positive from COVID-19 ]
    Proportion of study participants receiving invasive ventilation within 21 days of testing positive


Other Outcome Measures:
  1. Reported symptom severity [ Time Frame: 21 days from testing positive from COVID-19 ]
    Modified BORG scale, visual analog scale for fatigue

  2. Adverse events [ Time Frame: 21 days from testing positive from COVID-19 ]
    Diarrhea, nausea, abdominal cramping



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 presenting to a Mount Carmel Health System (MCHS) Emergency Department (ED) or drive-through COVID-19 testing station, the Enhanced Urgent Care center in Hilliard (EUC), or other ambulatory MCHS facility who test positive for infection with SARS-CoV-2.
  • Age ≥45 years
  • Mild COVID-19 based on WHO Baseline Severity Categorization
  • Symptom duration ≤ 7 days
  • 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)
  • End stage liver disease or Hepatitis C
  • Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine
  • 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

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


Contacts
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Contact: Marvin R McCreary (614) 526-8432 supplement4covid19@gmail.com

Sponsors and Collaborators
Marvin McCreary, MD
Investigators
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Principal Investigator: Marvin R McCreary Mount Carmel Health System
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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 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Resveratrol
Stilbene
Vitamin D3
Cholecalciferol
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