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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Sponsors and Collaborators

Marvin McCreary, MD

Investigators

• Principal Investigator: Marvin R McCreary; Mount Carmel Health System

More Information

• 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
• Last Update Posted: May 26, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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