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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

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ClinicalTrials.gov Identifier: NCT04400890
Recruitment Status : Active, not recruiting
First Posted : May 26, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Marvin McCreary, MD, Mount Carmel Health System

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 26, 2020
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE September 12, 2020
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • ICU Admission Rates [ Time Frame: 21 days from randomization ]
    Proportion of study participants admitted within 21 who subsequently get admitted to the ICU
  • 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.
  • Pneumonia [ Time Frame: 21 days from randomization ]
    Proportion of study participants are diagnosed with pneumonia with 21 day of randomization
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: September 12, 2020)
Adverse events [ Time Frame: 60 days from randomization ]
Diarrhea, nausea, abdominal cramping
Original Other Pre-specified Outcome Measures
 (submitted: May 22, 2020)
  • Reported symptom severity [ Time Frame: 21 days from testing positive from COVID-19 ]
    Modified BORG scale, visual analog scale for fatigue
  • Adverse events [ Time Frame: 21 days from testing positive from COVID-19 ]
    Diarrhea, nausea, abdominal cramping
 
Descriptive Information
Brief Title  ICMJE Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
Official Title  ICMJE Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Resveratrol with Vitamin D3
    Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
    Interventions:
    • Drug: Resveratrol
    • Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo with Vitamin D3
    Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1
    Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 4, 2021)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
200
Estimated Study Completion Date  ICMJE March 2021
Actual Primary Completion Date January 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04400890
Other Study ID Numbers  ICMJE McCreary2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Marvin McCreary, MD, Mount Carmel Health System
Study Sponsor  ICMJE Marvin McCreary, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marvin R McCreary Mount Carmel Health System
PRS Account Mount Carmel Health System
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP