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

• Status: Terminated
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marvin McCreary, MD
• Treatments: Cholecalciferol; Resveratrol; Vitamin D

Criteria

Inclusion Criteria:

• 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

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 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.

• 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